New Drug Approvals Archive for 2020

Ayvakit (avapritinib) Tablets

Date of Approval: January 9, 2020
Company: Blueprint Medicines Corporation
Treatment for: Gastrointestinal Stromal Tumor, Systemic Mastocytosis

Ayvakit (avapritinib) is a tyrosine kinase inhibitor for use in the treatment of gastrointestinal stromal tumors, advanced systemic mastocytosis, and indolent systemic mastocytosis.

• FDA Approves Ayvakit (avapritinib) for the Treatment of Adults with Unresectable or Metastatic PDGFRA Exon 18 Mutant Gastrointestinal Stromal Tumor
• Ayvakit (avapritinib) FDA Approval History

Valtoco (diazepam) Nasal Spray

Date of Approval: January 10, 2020
Company: Neurelis, Inc.
Treatment for: Epilepsy

Valtoco (diazepam) is a benzodiazepine nasal spray for the short-term treatment of epilepsy cluster seizures.

• FDA Approves Valtoco (diazepam nasal spray) as a Seizure Rescue Treatment
• Valtoco (diazepam) FDA Approval History

Numbrino (cocaine hydrochloride) Nasal Solution

Date of Approval: January 10, 2020
Company: Lannett Company, Inc.
Treatment for: Nasal Anesthesia

Numbrino (cocaine hydrochloride) nasal solution is a local anesthetic indicated for the introduction of local anesthesia of the mucous membranes for diagnostic procedures and surgeries on or through the nasal cavities of adults.

• FDA Approves Numbrino (cocaine hydrochloride) Nasal Solution for Nasal Anesthesia
• Numbrino (cocaine hydrochloride) FDA Approval History

Tepezza (teprotumumab-trbw) Injection

Date of Approval: January 21, 2020
Company: Horizon Therapeutics plc
Treatment for: Thyroid Eye Disease

Tepezza (teprotumumab-trbw) is a fully human monoclonal antibody (mAb) and a targeted inhibitor of the insulin-like growth factor 1 receptor (IGF-1R) for the treatment of active thyroid eye disease (TED).

• FDA Approves Tepezza (teprotumumab-trbw) for the Treatment of Thyroid Eye Disease (TED)
• Tepezza (teprotumumab-trbw) FDA Approval History

Tazverik (tazemetostat) Tablets

Date of Approval: January 23, 2020
Company: Epizyme, Inc.
Treatment for: Epithelioid Sarcoma; Follicular Lymphoma

Tazverik (tazemetostat) is a methyltransferase inhibitor for the treatment of:

• adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
• Adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least 2 prior systemic therapies.
• Adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options.

These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

• FDA Approves Tazverik (tazemetostat) for the Treatment of Patients with Epithelioid Sarcoma
• Tazverik (tazemetostat) FDA Approval History

Trijardy XR (empagliflozin, linagliptin and metformin hydrochloride) Extended-Release Tablets

Date of Approval: January 27, 2020
Company: Boehringer Ingelheim and Eli Lilly and Company
Treatment for: Diabetes, Type 2

Trijardy XR (empagliflozin/linagliptin/metformin hydrochloride) is a fixed-dose combination of the sodium-glucose cotransporter 2 (SGLT2) inhibitor empagliflozin (Jardiance), the dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin (Tradjenta) and the biguanide metformin hydrochloride indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

• FDA Approves Trijardy XR (empagliflozin/linagliptin/metformin) for Type 2 Diabetes in Adults
• Trijardy XR (empagliflozin, linagliptin and metformin hydrochloride) FDA Approval History

Monoferric (ferric derisomaltose) Injection

Date of Approval: January 16, 2020
Company: Pharmacosmos Therapeutics Inc.
Treatment for: Iron Deficiency Anemia

Monoferric (ferric derisomaltose) is an intravenous iron replacement product indicated for the treatment of iron deficiency anemia.

• FDA Approves Monoferric (ferric derisomaltose) Injection for the Treatment of Iron Deficiency Anemia
• Monoferric (ferric derisomaltose) FDA Approval History

Palforzia (Peanut (Arachis hypogaea) Allergen Powder-dnfp) - formerly AR101

Date of Approval: January 31, 2020
Company: Aimmune Therapeutics, Inc.
Treatment for: Peanut Allergy

Palforzia (Peanut (Arachis hypogaea) Allergen Powder-dnfp) is an oral immunotherapy indicated to help reduce the severity of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut.

• FDA Approves Palforzia [Peanut (Arachis hypogaea) Allergen Powder-dnfp] as First Treatment for Peanut Allergy
• Palforzia (Peanut (Arachis hypogaea) Allergen Powder-dnfp) FDA Approval History

Audenz (influenza A (H5N1) monovalent vaccine, adjuvanted) Injection

Date of Approval: January 31, 2020
Company: Seqirus
Treatment for: Influenza Prophylaxis

Audenz (influenza A (H5N1) monovalent vaccine, adjuvanted) is a cell-based influenza vaccine designed to protect against influenza A (H5N1) in the event of a pandemic.

• FDA Approves Audenz (Influenza A (H5N1) Monovalent Vaccine, Adjuvanted) as First-Ever Adjuvanted, Cell-Based Pandemic Influenza A (H5N1) Vaccine
• Audenz (influenza A (H5N1) monovalent vaccine, adjuvanted) FDA Approval History

Pemfexy (pemetrexed) Injection

Date of Approval: February 8, 2020
Company: Eagle Pharmaceuticals, Inc.
Treatment for: Non-Small Cell Lung Cancer, Malignant Pleural Mesothelioma

Pemfexy (pemetrexed for injection) is a branded alternative to Alimta for the treatment of nonsquamous non-small cell lung cancer and malignant pleural mesothelioma.

• FDA Approves Pemfexy (pemetrexed for injection) as a Branded Alternative to Alimta
• Pemfexy (pemetrexed) FDA Approval History

Pizensy (lactitol) Powder for Oral Solution

Date of Approval: February 12, 2020
Company: Braintree Laboratories, Inc.
Treatment for: Chronic Idiopathic Constipation

Pizensy (lactitol) is an osmotic laxative indicated for the treatment of chronic idiopathic constipation (CIC) in adults.

• FDA Approves Pizensy (lactitol) for the Treatment of Chronic Idiopathic Constipation (CIC)
• Pizensy (lactitol) FDA Approval History

Twirla (ethinyl estradiol and levonorgestrel) Transdermal System

Date of Approval: February 14, 2020
Company: Agile Therapeutics, Inc.
Treatment for: Birth Control

Twirla (ethinyl estradiol and levonorgestrel transdermal system) is a low-dose combined hormonal contraceptive patch for birth control.

• FDA Approves Twirla (levonorgestrel and ethinyl estradiol) Contraceptive Patch
• Twirla (ethinyl estradiol and levonorgestrel) FDA Approval History

Anjeso (meloxicam) Injection

Date of Approval: February 20, 2020
Company: Baudax Bio, Inc.
Treatment for: Pain

Anjeso (meloxicam) is a non-steroidal anti-inflammatory drug (NSAID) injection indicated for use in adults for the management of moderate-to-severe pain, alone or in combination with non-NSAID analgesics.

• FDA Approves Anjeso (meloxicam injection) for the Management of Moderate to Severe Pain
• Anjeso (meloxicam) FDA Approval History

Nexletol (bempedoic acid) Tablets

Date of Approval: February 21, 2020
Company: Esperion Therapeutics, Inc.
Treatment for: High Cholesterol, Familial Heterozygous, Cardiovascular Risk Reduction

Nexletol (bempedoic acid) is an adenosine triphosphate-citrate lyase (ACL) inhibitor used for cardiovascular risk reduction and the treatment of primary hyperlipidemia.

• FDA Approves Nexletol (bempedoic acid) to Lower LDL-Cholesterol
• Nexletol (bempedoic acid) FDA Approval History

Vyepti (eptinezumab-jjmr) Injection

Date of Approval: February 21, 2020
Company: Lundbeck
Treatment for: Migraine Prevention

Vyepti (eptinezumab-jjmr) is a calcitonin gene-related peptide antagonist indicated for the prevention of migraine in adults.

• FDA Approves Vyepti (eptinezumab-jjmr) Intravenous Injection for the Preventive Treatment of Migraine
• Vyepti (eptinezumab-jjmr) FDA Approval History

Fluad Quadrivalent (influenza vaccine, adjuvanted) Injection

Date of Approval: February 21, 2020
Company: Seqirus
Treatment for: Influenza Prophylaxis

Fluad Quadrivalent (influenza vaccine, adjuvanted) is an inactivated influenza virus vaccine approved for the prevention of seasonal influenza in adults 65 years and older.

• FDA Approves Fluad Quadrivalent (influenza vaccine, adjuvanted) for Influenza Prophylaxis in Adults 65 Years and Older
• Fluad Quadrivalent (influenza vaccine, adjuvanted) FDA Approval History

Nexlizet (bempedoic acid and ezetimibe) Tablets

Date of Approval: February 26, 2020
Company: Esperion Therapeutics
Treatment for: High Cholesterol, Familial Heterozygous

Nexlizet (bempedoic acid and ezetimibe) is an adenosine triphosphate-citrate lyase (ACL) inhibitor and a cholesterol absorption inhibitor combination used for the treatment of primary hyperlipidemia.

• FDA Approves Nexlizet (bempedoic acid and ezetimibe) to Lower LDL-Cholesterol
• Nexlizet (bempedoic acid and ezetimibe) FDA Approval History

Barhemsys (amisulpride) Injection

Date of Approval: February 26, 2020
Company: Acacia Pharma
Treatment for: Nausea/Vomiting, Postoperative

Barhemsys (amisulpride) is a dopamine-2 (D₂) antagonist for the management of post-operative nausea and vomiting (PONV).

• FDA Approves Barhemsys (amisulpride) for the Treatment and Prevention of Postoperative Nausea and Vomiting
• Barhemsys (amisulpride) FDA Approval History

Nurtec ODT (rimegepant) Orally Disintegrating Tablets (ODT)

Date of Approval: February 27, 2020
Company: Biohaven Pharmaceutical Holding Company Ltd.
Treatment for: <a href="https://www.drugs.com/condition/migraine.html">Migraine</a>; <a href="https://www.drugs.com/condition/migraine-prophylaxis.html">Migraine Prophylaxis</a>

Nurtec ODT (rimegepant) is an orally-dosed calcitonin gene-related peptide (CGRP) receptor antagonist for the acute treatment of migraine with or without aura, and the preventive treatment of episodic migraine, in adults.

• FDA Approves Nurtec ODT (rimegepant) for the Acute Treatment of Migraine in Adults
• Nurtec ODT (rimegepant) FDA Approval History

Advil Dual Action (ibuprofen and acetaminophen) Tablets

Date of Approval: February 28, 2020
Company: GSK Consumer Healthcare
Treatment for: Pain

Advil Dual Action (ibuprofen with acetaminophen) is an over-the-counter (OTC) fixed-dose combination of ibuprofen (the nonsteroidal anti-inflammatory drug (NSAID) contained in Advil) and acetaminophen (the active ingredient in Tylenol) for the relief of pain.

• FDA Approves Advil Dual Action (ibuprofen and acetaminophen) as an Over-the-Counter Pain Treatment
• Advil Dual Action (ibuprofen and acetaminophen) FDA Approval History

Sarclisa (isatuximab-irfc) Injection

Date of Approval: March 2, 2020
Company: Sanofi
Treatment for: Multiple Myeloma

• in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor.
• in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy.

• FDA Approves Sarclisa (isatuximab-irfc) for Patients with Relapsed Refractory Multiple Myeloma
• Sarclisa (isatuximab-irfc) FDA Approval History

Pizensy (lactitol) Powder for Oral Solution

Date of Approval: February 12, 2020
Company: Braintree Laboratories, Inc.
Treatment for: Chronic Idiopathic Constipation

Pizensy (lactitol) is an osmotic laxative indicated for the treatment of chronic idiopathic constipation (CIC) in adults.

• FDA Approves Pizensy (lactitol) for the Treatment of Chronic Idiopathic Constipation in Adults
• Pizensy (lactitol) FDA Approval History

Durysta (bimatoprost) Implant

Date of Approval: March 3, 2020
Company: Allergan plc
Treatment for: Glaucoma, Open Angle, Intraocular Hypertension

Durysta (bimatoprost implant) is a prostaglandin analog indicated for the reduction of intraocular pressure (IOP) in patients with open angle glaucoma (OAG) or ocular hypertension (OHT).

• FDA Approves Durysta (bimatoprost implant) to Lower Intraocular Pressure In Open-Angle Glaucoma or Ocular Hypertension Patients
• Durysta (bimatoprost) FDA Approval History

Isturisa (osilodrostat) Tablets

Date of Approval: March 6, 2020
Company: Novartis Pharmaceuticals Corporation
Treatment for: Cushing's Syndrome

Isturisa (osilodrostat) is a cortisol synthesis inhibitor indicated for the treatment of adult patients with Cushing’s disease.

• FDA Approves Isturisa (osilodrostat) for the Treatment of Cushing’s Disease
• Isturisa (osilodrostat) FDA Approval History

Zeposia (ozanimod) Capsules

Date of Approval: March 25, 2020
Company: Bristol-Myers Squibb Company
Treatment for: Multiple Sclerosis, Ulcerative Colitis

Zeposia (ozanimod) is a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults; and moderately to severely active ulcerative colitis (UC) in adults.

• FDA Approves Zeposia (ozanimod) for Relapsing Forms of Multiple Sclerosis
• Zeposia (ozanimod) FDA Approval History

Sevenfact (coagulation factor VIIa (recombinant)-jncw) Injection

Date of Approval: April 1, 2020
Company: HEMA Biologics, LLC
Treatment for: Hemophilia A or B with Inhibitors

Sevenfact (coagulation factor VIIa [recombinant]-jncw) is a coagulation factor VIIa concentrate indicated for the treatment and control of bleeding episodes occurring in adults and adolescents 12 years of age and older with hemophilia A or B with inhibitors (neutralizing antibodies).

• FDA Approves Sevenfact [coagulation factor VIIa (recombinant)-jncw] for Treatment and Control of Bleeding Episodes Occurring in Adult and Adolescent Hemophilia A and B Patients with Inhibitors
• Sevenfact (coagulation factor VIIa (recombinant)-jncw) FDA Approval History

Koselugo (selumetinib) Capsules

Date of Approval: April 10, 2020
Company: AstraZeneca and Merck
Treatment for: Neurofibromatosis Type 1

Koselugo (selumetinib) is an inhibitor of mitogen-activated protein kinase kinases 1 and 2 (MEK1/2) indicated for the treatment of pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN).

• FDA Approves Koselugo (selumetinib) for Pediatric Patients with Neurofibromatosis Type 1 Plexiform Neurofibromas
• Koselugo (selumetinib) FDA Approval History

Jelmyto (mitomycin) for Pyelocalyceal Solution

Date of Approval: April 15, 2020
Company: UroGen Pharma Ltd.
Treatment for: Urothelial Carcinoma

Jelmyto (mitomycin) is a novel formulation of the approved alkylating drug mitomycin for the treatment of patients with low-grade upper tract urothelial cancer (LG-UTUC).

• FDA Approves Jelmyto (mitomycin) for Treatment of Low-Grade Upper Tract Urothelial Cancer
• Jelmyto (mitomycin) FDA Approval History

Tukysa (tucatinib) Tablets

Date of Approval: April 17, 2020
Company: Seattle Genetics, Inc.
Treatment for: Breast Cancer, Colorectal Cancer

Tukysa (tucatinib) is a kinase inhibitor used for the combination treatment of HER2-positive breast cancer and RAS wild-type HER2-positive colorectal cancer.

• FDA Approves Tukysa (tucatinib) for People with Advanced Unresectable or Metastatic HER2-Positive Breast Cancer
• Tukysa (tucatinib) FDA Approval History

Pemazyre (pemigatinib) Tablets

Date of Approval: April 17, 2020
Company: Incyte Corporation
Treatment for: Cholangiocarcinoma, Myeloid/Lymphoid Neoplasms

Pemazyre (pemigatinib) is a selective fibroblast growth factor receptor (FGFR) inhibitor for the treatment of adults with cholangiocarcinoma with FGFR2 rearrangement, and myeloid/lymphoid neoplasms with FGFR1 rearrangement.

• FDA Approves Pemazyre (pemigatinib) as First Targeted Treatment for Adults with Previously Treated, Unresectable Locally Advanced or Metastatic Cholangiocarcinoma
• Pemazyre (pemigatinib) FDA Approval History

Emerphed (ephedrine sulfate) Injection

Date of Approval: April 17, 2020
Company: Nexus Pharmaceuticals, Inc.
Treatment for: Hypotension

Emerphed (ephedrine sulfate) is a ready-to-use formulation of the approved pressor agent ephedrine indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia.

• FDA Approves Emerphed (ephedrine sulfate) Ready-to-Use Injection for Hypotension During Anesthesia
• Emerphed (ephedrine sulfate) FDA Approval History

Trodelvy (sacituzumab govitecan-hziy) Injection

Date of Approval: April 22, 2020
Company: Immunomedics, Inc.
Treatment for: Breast Cancer, Urothelial Carcinoma

Trodelvy (sacituzumab govitecan-hziy) is a Trop-2-directed antibody and topoisomerase inhibitor conjugate used for the treatment of breast cancer and urothelial cancer.

• FDA Approves Trodelvy (sacituzumab govitecan-hziy) for Previously-Treated Metastatic Triple Negative Breast Cancer
• Trodelvy (sacituzumab govitecan-hziy) FDA Approval History

MenQuadfi (meningococcal (groups A, C, Y, W) conjugate vaccine) Injection

Date of Approval: April 23, 2020
Company: Sanofi
Treatment for: Meningococcal Disease Prophylaxis

MenQuadfi (meningococcal (groups A, C, Y, W) conjugate vaccine) is a MenACWY vaccine indicated for active immunization for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y in individuals 2 years of age and older.

• FDA Approves MenQuadfi (Meningococcal (Groups A, C, Y, W) Conjugate Vaccine) for Meningococcal (MenACWY) Vaccination
• MenQuadfi (meningococcal (groups A, C, Y, W) conjugate vaccine) FDA Approval History

Ongentys (opicapone) Capsules

Date of Approval: April 24, 2020
Company: Neurocrine Biosciences, Inc.
Treatment for: Parkinson's Disease

Ongentys (opicapone) is a catechol-O-methyltransferase (COMT) inhibitor indicated as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease (PD) experiencing “off” episodes.

• FDA Approves Ongentys (opicapone) as an Add-On Treatment for Patients with Parkinson’s Disease Experiencing “Off” Episodes
• Ongentys (opicapone) FDA Approval History

Bafiertam (monomethyl fumarate) Delayed-Release Capsules

Date of Approval: April 28, 2020
Company: Banner Life Sciences LLC
Treatment for: Multiple Sclerosis

Bafiertam (monomethyl fumarate) is a novel fumarate indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

• FDA Approves Bafiertam (monomethyl fumarate) for Multiple Sclerosis
• Bafiertam (monomethyl fumarate) FDA Approval History

Darzalex Faspro (daratumumab and hyaluronidase-fihj) Injection

Date of Approval: May 1, 2020
Company: The Janssen Pharmaceutical Companies of Johnson & Johnson
Treatment for: Multiple Myeloma; Light Chain (AL) Amyloidosis

Darzalex Faspro (daratumumab and hyaluronidase-fihj) is a combination of daratumumab, a CD38-directed cytolytic antibody, and hyaluronidase, an endoglycosidase, indicated for the treatment of multiple myeloma and light chain (AL) amyloidosis.

• FDA Approves Darzalex Faspro (daratumumab and hyaluronidase-fihj) for the Treatment of Patients with Multiple Myeloma
• Darzalex Faspro (daratumumab and hyaluronidase-fihj) FDA Approval History

Fensolvi (leuprolide acetate) Injection

Date of Approval: May 1, 2020
Company: Tolmar Pharmaceuticals, Inc.
Treatment for: Precocious Puberty

Fensolvi (leuprolide acetate) is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of pediatric patients 2 years of age and older with central precocious puberty.

• FDA Approves Fensolvi (leuprolide acetate) for Injectable Suspension for Pediatric Patients with Central Precocious Puberty
• Fensolvi (leuprolide acetate) FDA Approval History

Elyxyb (celecoxib) Oral Solution

Date of Approval: May 5, 2020
Company: Dr. Reddy’s Laboratories Limited
Treatment for: Migraine

Elyxyb (celecoxib) is an oral solution formulation of the nonsteroidal anti-inflammatory drug celecoxib (first approved under the brand name Celebrex) indicated for the acute treatment of migraine with or without aura in adults.

• FDA Approves Elyxyb (celecoxib) Oral Solution For Acute Treatment Of Migraine With Or Without Aura In Adults
• Elyxyb (celecoxib) FDA Approval History

Tabrecta (capmatinib) Tablets

Date of Approval: May 6, 2020
Company: Novartis
Treatment for: Non-Small Cell Lung Cancer

Tabrecta (capmatinib) is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test.

• FDA Approves Tabrecta (capmatinib) for Metastatic Non-Small Cell Lung Cancer with METex14
• Tabrecta (capmatinib) FDA Approval History

Retevmo (selpercatinib) Capsules and Tablets

Date of Approval: May 8, 2020
Company: Eli Lilly and Company
Treatment for: Non-Small Cell Lung Cancer, Thyroid Cancer, Solid Tumors

Retevmo (selpercatinib) is a kinase inhibitor used for the treatment of certain cancers caused by abnormal RET genes.

• FDA Approves Retevmo (selpercatinib) for Patients with Advanced RET-Driven Lung and Thyroid Cancers
• Retevmo (selpercatinib) FDA Approval History

Qinlock (ripretinib) Tablets

Date of Approval: May 15, 2020
Company: Deciphera Pharmaceuticals, Inc.
Treatment for: Gastrointestinal Stromal Tumor

Qinlock (ripretinib) is a broad-spectrum KIT and PDGFRα inhibitor for the treatment of patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib.

• FDA Approves Qinlock (ripretinib) for the Treatment of Fourth-Line Gastrointestinal Stromal Tumor
• Qinlock (ripretinib) FDA Approval History

Kynmobi (apomorphine hydrochloride) Sublingual Film

Date of Approval: May 21, 2020
Company: Sunovion Pharmaceuticals Inc.
Treatment for: Parkinson's Disease

Kynmobi (apomorphine sublingual film) is a novel formulation of the approved dopamine agonist apomorphine for the on-demand management of OFF episodes associated with Parkinson’s disease (PD).

• FDA Approves Kynmobi (apomorphine hydrochloride) Sublingual Film for the Treatment of Parkinson’s Disease OFF Episodes
• Kynmobi (apomorphine hydrochloride) FDA Approval History

Phexxi (lactic acid, citric acid and potassium bitartrate) Vaginal Gel - formerly Amphora

Date of Approval: May 22, 2020
Company: Evofem, Inc.
Treatment for: Birth Control

Phexxi (lactic acid, citric acid and potassium bitartrate) is a non-hormonal vaginal gel indicated for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception.

• FDA Approves Phexxi (lactic acid, citric acid and potassium bitartrate) Non-Hormonal Prescription Gel for the Prevention of Pregnancy
• Phexxi (lactic acid, citric acid and potassium bitartrate) FDA Approval History

Cerianna (fluoroestradiol F18) Injection

Date of Approval: May 20, 2020
Company: Zionexa USA
Treatment for: Diagnosis and Investigation

Cerianna (fluoroestradiol F18) is a radioactive diagnostic agent indicated for use with positron emission tomography (PET) imaging for the detection of estrogen receptor (ER)-positive lesions as an adjunct to biopsy in patients with recurrent or metastatic breast cancer.

• FDA Approves Cerianna (fluoroestradiol F18) PET Imaging Agent for Use in Patients with Recurrent or Metastatic Breast Cancer
• Cerianna (fluoroestradiol F18) FDA Approval History

(artesunate) for Injection

Date of Approval: May 26, 2020
Company: Amivas (US), LLC
Treatment for: Malaria

Artesunate for Injection is an antimalarial indicated for the initial treatment of severe malaria in adult and pediatric patients.

• FDA Approves Artesunate for Injection for the Treatment of Severe Malaria
• artesunate FDA Approval History

Tauvid (flortaucipir F 18) Injection

Date of Approval: May 28, 2020
Company: Eli Lilly and Company
Treatment for: Diagnosis and Investigation

Tauvid (flortaucipir F 18) is a radioactive diagnostic agent indicated for positron emission tomography (PET) imaging of the brain to estimate the density and distribution of aggregated tau neurofibrillary tangles (NFTs) in adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD).

• FDA Approves Tauvid (flortaucipir F 18 injection) for Use in Patients Being Evaluated for Alzheimer's Disease
• Tauvid (flortaucipir F 18) FDA Approval History

Zilxi (minocycline) Topical Foam - formerly FMX103

Date of Approval: May 28, 2020
Company: Foamix Pharmaceuticals Ltd.
Treatment for: Rosacea

Zilxi (minocycline) is a topical tetracycline formulation indicated for the treatment of inflammatory lesions of rosacea in adults.

• FDA Approves Zilxi (minocycline) Topical Foam for the Treatment of Rosacea
• Zilxi (minocycline) FDA Approval History

Oriahnn (elagolix/estradiol/norethindrone acetate and elagolix) Capsules

Date of Approval: May 29, 2020
Company: AbbVie Inc.
Treatment for: Uterine Leiomyomata

Oriahnn (elagolix/estradiol/norethindrone acetate and elagolix) is a gonadotropin-releasing hormone (GnRH) receptor antagonist, estrogen and progestin co-formulation indicated for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women.

• FDA Approves Oriahnn (elagolix/estradiol/norethindrone acetate and elagolix) for the Management of Heavy Menstrual Bleeding Due to Uterine Fibroids in Pre-Menopausal Women
• Oriahnn (elagolix/estradiol/norethindrone acetate and elagolix) FDA Approval History

Nyvepria (pegfilgrastim-apgf) Injection

Date of Approval: June 10, 2020
Company: Pfizer Inc.
Treatment for: Neutropenia Associated with Chemotherapy

Nyvepria (pegfilgrastim-apgf) is a PEGylated growth colony-stimulating factor biosimilar to Neulasta (pegfilgrastim) used to reduce the incidence of febrile neutropenia in patients treated with chemotherapy.

• FDA Approves Nyvepria (pegfilgrastim-apgf), a Biosimilar to Neulasta
• Nyvepria (pegfilgrastim-apgf) FDA Approval History

Semglee (insulin glargine-yfgn) Injection

Date of Approval: June 11, 2020
Company: Mylan Pharmaceuticals Inc.
Treatment for: Diabetes, Type 1, Diabetes, Type 2

Semglee (insulin glargine-yfgn) is a long-acting human insulin analog biosimilar to Lantus (insulin glargine) indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus, and adults with type 2 diabetes mellitus.

• FDA Approves Semglee (insulin glargine injection) for Type 1 and Type 2 Diabetes
• Semglee (insulin glargine-yfgn) FDA Approval History

Uplizna (inebilizumab-cdon) Injection

Date of Approval: June 11, 2020
Company: Viela Bio
Treatment for: Neuromyelitis Optica Spectrum Disorder (NMOSD)

Uplizna (inebilizumab-cdon) is a CD19-directed cytolytic antibody indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

• FDA Approves Uplizna (inebilizumab-cdon) for the Treatment of Neuromyelitis Optica Spectrum Disorder (NMOSD)
• Uplizna (inebilizumab-cdon) FDA Approval History

Lyumjev (insulin lispro-aabc) Injection

Date of Approval: June 15, 2020
Company: Eli Lilly and Company
Treatment for: Diabetes, Type 1, Diabetes, Type 2

Lyumjev (insulin lispro-aabc) is a rapid-acting human insulin analog indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.

• FDA Approves Lyumjev (insulin lispro-aabc injection) for Type 1 and Type 2 Diabetes
• Lyumjev (insulin lispro-aabc) FDA Approval History

Zepzelca (lurbinectedin) Injection

Date of Approval: June 15, 2020
Company: PharmaMar and Jazz Pharmaceuticals plc
Treatment for: Small Cell Lung Cancer

Zepzelca (lurbinectedin) is a selective oncogenic transcription inhibitor indicated for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.

• FDA Approves Zepzelca (lurbinectedin) for the Treatment of Metastatic Small Cell Lung Cancer
• Zepzelca (lurbinectedin) FDA Approval History

Gimoti (metoclopramide) Nasal Spray

Date of Approval: June 19, 2020
Company: Evoke Pharma, Inc.
Treatment for: Gastroparesis

Gimoti (metoclopramide) is an intranasal formulation of the approved drug metoclopramide for the relief of symptoms of acute and recurrent diabetic gastroparesis in adults.

• FDA Approves Gimoti (metoclopramide) Nasal Spray for Diabetic Gastroparesis
• Gimoti (metoclopramide) FDA Approval History

Fintepla (fenfluramine) Oral Solution

Date of Approval: June 25, 2020
Company: Zogenix, Inc.
Treatment for: Dravet Syndrome, Lennox-Gastaut Syndrome

Fintepla (fenfluramine) is an amphetamine derivative indicated for the treatment of seizures associated with Dravet syndrome and Lennox-Gastaut syndrome in patients 2 years of age and older.

• FDA Approves Fintepla (fenfluramine) for the Treatment of Seizures Associated with Dravet Syndrome
• Fintepla (fenfluramine) FDA Approval History

Mycapssa (octreotide) Delayed-Release Capsules

Date of Approval: June 26, 2020
Company: Chiasma, Inc.
Treatment for: Acromegaly

Mycapssa (octreotide) is an oral formulation of the approved somatostatin analog octreotide for the treatment of acromegaly.

• FDA Approves Mycapssa (octreotide) Oral Somatostatin Analog for Acromegaly
• Mycapssa (octreotide) FDA Approval History

Phesgo (pertuzumab, trastuzumab, and hyaluronidase-zzxf) Injection

Date of Approval: June 29, 2020
Company: Genentech
Treatment for: Breast Cancer

Phesgo (pertuzumab, trastuzumab, and hyaluronidase-zzxf) is a combination of two HER2/neu receptor antagonists and the endoglycosidase hyaluronidase indicated for the treatment of early and metastatic HER2-positive breast cancer, as detected by an FDA-approved companion diagnostic test.

• FDA Approves Phesgo (pertuzumab, trastuzumab, and hyaluronidase-zzxf) for HER2-Positive Breast Cancer
• Phesgo (pertuzumab, trastuzumab, and hyaluronidase-zzxf) FDA Approval History

Dojolvi (triheptanoin) Oral Liquid

Date of Approval: June 30, 2020
Company: Ultragenyx Pharmaceutical Inc.
Treatment for: Long-Chain Fatty Acid Oxidation Disorders

Dojolvi (triheptanoin) is a medium-chain triglyceride indicated as a source of calories and fatty acids for the treatment of pediatric and adult patients with molecularly confirmed long-chain fatty acid oxidation disorders (LC-FAOD).

• FDA Approves Dojolvi (triheptanoin) for the Treatment of Long-Chain Fatty Acid Oxidation Disorders
• Dojolvi (triheptanoin) FDA Approval History

Byfavo (remimazolam) Injection

Date of Approval: July 2, 2020
Company: Cosmo Pharmaceuticals NV
Treatment for: Sedation

Byfavo (remimazolam) is an ultra-short-acting, intravenous benzodiazepine sedative/anesthetic for the induction and maintenance of procedural sedation in adults.

• FDA Approves Byfavo (remimazolam injection) for the Induction and Maintenance of Procedural Sedation
• Byfavo (remimazolam) FDA Approval History

Rukobia (fostemsavir) Extended-Release Tablets

Date of Approval: July 2, 2020
Company: ViiV Healthcare
Treatment for: HIV Infection

Rukobia (fostemsavir) is a first-in-class, human immunodeficiency virus type 1 (HIV-1) gp120-directed attachment inhibitor indicated for use in combination with other antiretroviral(s) for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection.

• FDA Approves Rukobia (fostemsavir) for HIV in Adults with Few Treatment Options Available
• Rukobia (fostemsavir) FDA Approval History

Qwo (collagenase clostridium histolyticum-aaes) for Injection

Date of Approval: July 6, 2020
Company: Endo International plc
Treatment for: Cellulite

Qwo (collagenase clostridium histolyticum-aaes) is a combination of bacterial collagenases indicated for the treatment of moderate to severe cellulite in the buttocks of adult women.

• FDA Approves Qwo (collagenase clostridium histolyticum-aaes) as the First Injectable Treatment for Cellulite
• Qwo (collagenase clostridium histolyticum-aaes) FDA Approval History

Inqovi (decitabine and cedazuridine) Tablets

Date of Approval: July 7, 2020
Company: Astex Pharmaceuticals, Taiho Oncology, and Otsuka Pharmaceutical
Treatment for: Myelodysplastic Syndrome

Inqovi (decitabine and cedazuridine) is a nucleoside metabolic inhibitor and cytidine deaminase inhibitor combination indicated for the treatment of adults with intermediate and high-risk myelodysplastic syndromes (MDS) including chronic myelomonocytic leukemia (CMML).

• FDA Approves Inqovi (decitabine and cedazuridine) for Myelodysplastic Syndromes (MDS) including Chronic Myelomonocytic Leukemia (CMML)
• Inqovi (decitabine and cedazuridine) FDA Approval History

Hulio (adalimumab-fkjp) Injection

Date of Approval: July 6, 2020
Company: Mylan Pharmaceuticals Inc.
Treatment for: Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Crohn's Disease, Ulcerative Colitis, Plaque Psoriasis, Hidradenitis Suppurativa, Uveitis

Hulio (adalimumab-fkjp) is a tumor necrosis factor (TNF) blocker biosimilar to Humira indicated for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis.

• FDA Approves Hulio (adalimumab-fkjp), a Biosimilar to Humira
• Hulio (adalimumab-fkjp) FDA Approval History

Upneeq (oxymetazoline hydrochloride) Ophthalmic Solution

Date of Approval: July 8, 2020
Company: Osmotica Pharmaceuticals plc
Treatment for: Blepharoptosis

Upneeq (oxymetazoline hydrochloride ophthalmic solution, 0.1%) is a once-daily ophthalmic formulation of the direct-acting alpha-adrenergic receptor agonist oxymetazoline indicated for the treatment of acquired blepharoptosis, or ptosis, a condition characterized by the abnormal drooping of the upper eyelid.

• FDA Approves Upneeq (oxymetazoline hydrochloride ophthalmic solution) for Acquired Blepharoptosis (Droopy Eyelid) in Adults
• Upneeq (oxymetazoline hydrochloride) FDA Approval History

Wynzora (calcipotriene and betamethasone dipropionate) Cream

Date of Approval: July 20, 2020
Company: MC2 Therapeutics
Treatment for: Plaque Psoriasis

Wynzora (calcipotriene and betamethasone dipropionate) is a PAD™ Cream formulation of the vitamin D analog calcipotriene, and the corticosteroid betamethasone dipropionate, indicated for the topical treatment of plaque psoriasis in patients 18 years of age and older.

• FDA Approves Wynzora Cream (calcipotriene and betamethasone dipropionate) for Adults with Plaque Psoriasis
• Wynzora (calcipotriene and betamethasone dipropionate) FDA Approval History

Xywav (calcium, magnesium, potassium, and sodium oxybates) Oral Solution

Date of Approval: July 21, 2020
Company: Jazz Pharmaceuticals plc
Treatment for: Narcolepsy; Idiopathic Hypersomnia

Xywav (calcium, magnesium, potassium, and sodium oxybates) is a low-sodium oxybate product for the treatment of cataplexy and excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy, and for the treatment of idiopathic hypersomnia (IH) in adults.

• FDA Approves Xywav (calcium, magnesium, potassium, and sodium oxybates) Oral Solution for Cataplexy or Excessive Daytime Sleepiness Associated with Narcolepsy
• Xywav (calcium, magnesium, potassium, and sodium oxybates) FDA Approval History

Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) Metered Dose Inhalation

Date of Approval: July 23, 2020
Company: AstraZeneca
Treatment for: COPD

Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) is a fixed dose triple-combination of the inhaled corticosteroid budesonide, the long-acting muscarinic antagonist (LAMA) glycopyrrolate, and the long-acting beta₂-agonist (LABA) formoterol fumarate, delivered in a pressurized metered-dose inhaler for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).

• FDA Approves Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) for the Maintenance Treatment of COPD
• Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) FDA Approval History

Tecartus (brexucabtagene autoleucel) Suspension for Intravenous Infusion - formerly KTE-X19

Date of Approval: July 24, 2020
Company: Kite, a Gilead Company
Treatment for: Mantle Cell Lymphoma

Tecartus (brexucabtagene autoleucel) is a CD19-directed genetically modified autologous T cell immunotherapy for the treatment of mantle cell lymphoma (MCL) and B-cell precursor acute lymphoblastic leukemia (ALL).

• FDA Approves Tecartus (brexucabtagene autoleucel) as the First and Only CAR T Treatment for Relapsed or Refractory Mantle Cell Lymphoma
• Tecartus (brexucabtagene autoleucel) FDA Approval History

Xeglyze (abametapir) Topical Lotion

Date of Approval: July 24, 2020
Company: Dr. Reddy’s Laboratories Ltd.
Treatment for: Head Lice

Xeglyze (abametapir) is a pediculicide indicated for the topical treatment of head lice infestation in patients 6 months of age and older.

• FDA Approves Xeglyze (abametapir) Lotion for the Treatment of Head Lice
• Xeglyze (abametapir) FDA Approval History

Monjuvi (tafasitamab-cxix) for Injection

Date of Approval: July 31, 2020
Company: MorphoSys AG
Treatment for: Diffuse Large B-Cell Lymphoma

Monjuvi (tafasitamab-cxix) is a CD19-directed cytolytic antibody indicated in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

• FDA Approves Monjuvi (tafasitamab-cxix) in Combination with Lenalidomide for the Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)
• Monjuvi (tafasitamab-cxix) FDA Approval History

Blenrep (belantamab mafodotin-blmf) Injection

Date of Approval: August 5, 2020
Company: GlaxoSmithKline plc
Treatment for: Multiple Myeloma

Blenrep (belantamab mafodotin-blmf) is a B-cell maturation antigen (BCMA)-directed antibody and microtubule inhibitor conjugate indicated for the treatment of adult patients with relapsed or refractory multiple myeloma.

• FDA Approves Blenrep (belantamab mafodotin-blmf) for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma
• Blenrep (belantamab mafodotin-blmf) FDA Approval History

Lampit (nifurtimox) Tablets

Date of Approval: August 6, 2020
Company: Bayer
Treatment for: Chagas Disease

Lampit (nifurtimox) is a nitrofuran antiprotozoal used for the treatment of Chagas disease (American Trypanosomiasis) in pediatric patients.

• FDA Approves Lampit (nifurtimox) for the Treatment of Chagas Disease in Children
• Lampit (nifurtimox) FDA Approval History

Evrysdi (risdiplam) for Oral Solution

Date of Approval: August 7, 2020
Company: Genentech
Treatment for: Spinal Muscular Atrophy

Evrysdi (risdiplam) is a survival of motor neuron 2 (SMN2) splicing modifier indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients.

• FDA Approves Evrysdi (risdiplam) for Treatment of Spinal Muscular Atrophy (SMA) in Adults and Children 2 Months and Older
• Evrysdi (risdiplam) FDA Approval History

Olinvyk (oliceridine) Injection - formerly Olinvo

Date of Approval: August 7, 2020
Company: Trevena, Inc.
Treatment for: Pain

Olinvyk (oliceridine) is an opioid agonist for the management of moderate to severe acute pain in adults.

• FDA Approves Olinvyk (oliceridine) Injection for the Management of Severe Acute Pain
• Olinvyk (oliceridine) FDA Approval History

Viltepso (viltolarsen) Injection

Date of Approval: August 12, 2020
Company: NS Pharma, Inc.
Treatment for: Duchenne Muscular Dystrophy

Viltepso (viltolarsen) is an antisense oliogonucleotide indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping.

• FDA Approves Viltepso (viltolarsen) for the Treatment of Duchenne Muscular Dystrophy in Patients Amenable to Exon 53 Skipping Therapy
• Viltepso (viltolarsen) FDA Approval History

Enspryng (satralizumab-mwge) Injection

Date of Approval: August 14, 2020
Company: Genentech
Treatment for: Neuromyelitis Optica Spectrum Disorder

Enspryng (satralizumab-mwge) is an interleukin-6 (IL-6) receptor antagonist indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

• FDA Approves Enspryng (satralizumab-mwge) for Neuromyelitis Optica Spectrum Disorder
• Enspryng (satralizumab-mwge) FDA Approval History

Kesimpta (ofatumumab) Injection

Date of Approval: August 20, 2020
Company: Novartis
Treatment for: Multiple Sclerosis

Kesimpta (ofatumumab) is a CD20-directed cytolytic antibody indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

• FDA Approves Kesimpta (ofatumumab) Targeted B-cell Therapy for Patients with Relapsing Multiple Sclerosis
• Kesimpta (ofatumumab) FDA Approval History

Cystadrops (cysteamine hydrochloride) Ophthalmic Solution

Date of Approval: August 19, 2020
Company: Recordati Rare Diseases Inc.
Treatment for: Corneal Cystine Crystal Accumulation

Cystadrops (cysteamine hydrochloride) is a cystine-depleting agent indicated for the treatment of corneal cystine crystal deposits in adults and children with cystinosis.

• FDA Approves Cystadrops (cysteamine) Ophthalmic Solution for the Ocular Manifestations of Cystinosis
• Cystadrops (cysteamine hydrochloride) FDA Approval History

Winlevi (clascoterone) Cream

Date of Approval: August 26, 2020
Company: Cassiopea SpA
Treatment for: Acne

Winlevi (clascoterone) cream is a first-in-class topical androgen receptor inhibitor indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.

• FDA Approves Winlevi (clascoterone) Cream for the Treatment of Acne
• Winlevi (clascoterone) FDA Approval History

Sogroya (somapacitan-beco) Injection

Date of Approval: August 28, 2020
Company: Novo Nordisk
Treatment for: Adult Human Growth Hormone Deficiency, Pediatric Growth Hormone Deficiency

Sogroya (somapacitan-beco) is a human growth hormone analog used for the treatment of people with growth hormone deficiency (GHD).

• FDA Approves Sogroya (somapacitan-beco) a Once-Weekly Treatment for Adult Growth Hormone Deficiency
• Sogroya (somapacitan-beco) FDA Approval History

Xaracoll (bupivacaine hydrochloride) Implant

Date of Approval: August 28, 2020
Company: Innocoll Holdings Limited
Treatment for: Postsurgical Pain Relief Following Open Inguinal Hernia

Xaracoll (bupivacaine hydrochloride) is a fully bioresorbable collagen implant containing the local anesthetic bupivacaine indicated for acute postsurgical pain relief for up to 24 hours in adults following open inguinal hernia repair.

• FDA Approves Xaracoll (bupivacaine hydrochloride) Implant for Acute Postsurgical Pain Relief Following Open Inguinal Hernia Repair
• Xaracoll (bupivacaine hydrochloride) FDA Approval History

Onureg (azacitidine) Tablets

Date of Approval: September 1, 2020
Company: Bristol Myers Squibb
Treatment for: Acute Myeloid Leukemia

Onureg (azacitidine) is a nucleoside metabolic inhibitor indicated for the continued treatment of adult patients with acute myeloid leukemia.

• FDA Approves Onureg (azacitidine tablets) as Continued Treatment for Adults in First Remission with Acute Myeloid Leukemia
• Onureg (azacitidine) FDA Approval History

Gavreto (pralsetinib) Capsules

Date of Approval: September 4, 2020
Company: Genentech, Inc.
Treatment for: Non-Small Cell Lung Cancer, Thyroid Cancer

Gavreto (pralsetinib) is an oral selective RET kinase inhibitor used for the treatment of rearranged during transfection (RET) fusion- positive non-small cell lung cancer (NSCLC), and RET-mutant medullary thyroid cancer (MTC).

• FDA Approves Gavreto (pralsetinib) for the Treatment of Adults With Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer
• Gavreto (pralsetinib) FDA Approval History

Detectnet (copper Cu 64 dotatate) Injection

Date of Approval: September 3, 2020
Company: RadioMedix Inc.
Treatment for: Positron Emission Tomography Imaging

Detectnet (copper Cu 64 dotatate) is a radioactive diagnostic agent indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult patients.

• FDA Approves Detectnet (copper Cu 64 dotatate injection) Positron Emission Tomography (PET) Agent
• Detectnet (copper Cu 64 dotatate) FDA Approval History

Qdolo (tramadol hydrochloride) Oral Solution

Date of Approval: September 1, 2020
Company: Athena Bioscience, LLC
Treatment for: Pain

Qdolo (tramadol hydrochloride) is an opioid agonist indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

• FDA Approves Qdolo (tramadol hydrochloride) Oral Solution for the Management of Severe Pain
• Qdolo (tramadol hydrochloride) FDA Approval History

Alkindi Sprinkle (hydrocortisone) Oral Granules

Date of Approval: September 29, 2020
Company: Eton Pharmaceuticals, Inc.
Treatment for: Adrenocortical Insufficiency

Alkindi Sprinkle (hydrocortisone granules in capsules for opening) is an immediate-release pediatric formulation of the approved glucocorticoid hydrocortisone for the treatment of adrenocortical insufficiency in infants, children and adolescents.

• FDA Approves Alkindi Sprinkle (hydrocortisone oral granules) for Pediatric Adrenocortical Insufficiency
• Alkindi Sprinkle (hydrocortisone) FDA Approval History

Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn) Injection

Date of Approval: October 14, 2020
Company: Regeneron Pharmaceuticals, Inc.
Treatment for: Zaire Ebolavirus infection

Inmazeb is (atoltivimab, maftivimab, and odesivimab) is a monoclonal antibody combination indicated for the treatment of Zaire ebolavirus infection in adults and children, including newborns of mothers who have tested positive for the virus.

• FDA Approves Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) Antibody Cocktail for Ebola (Zaire Ebolavirus)
• Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn) FDA Approval History

Veklury (remdesivir) Injection

Date of Approval: October 22, 2020
Company: Gilead Sciences, Inc.
Treatment for: COVID-19

Veklury (remdesivir) is a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor indicated for the treatment of COVID-19.

• FDA Approves Veklury (remdesivir) for the Treatment of COVID-19
• Veklury (remdesivir) FDA Approval History

Eysuvis (loteprednol etabonate) Ophthalmic Suspension

Date of Approval: October 26, 2020
Company: Kala Pharmaceuticals, Inc.
Treatment for: Dry Eye Disease

Eysuvis (loteprednol etabonate) is an ophthalmic corticosteroid formulation for the temporary relief of signs and symptoms of dry eye disease.

• FDA Approves Eysuvis (loteprednol etabonate) Ophthalmic Suspension for the Short-Term Treatment of the Signs and Symptoms of Dry Eye Disease
• Eysuvis (loteprednol etabonate) FDA Approval History

Bronchitol (mannitol) Inhalation Powder

Date of Approval: October 30, 2020
Company: Chiesi USA, Inc.
Treatment for: Cystic Fibrosis

Bronchitol (mannitol) is an inhaled dry powder formulation of the sugar alcohol mannitol indicated as add-on maintenance therapy to improve pulmonary function in adult patients 18 years of age and older with cystic fibrosis.

• FDA Approves Bronchitol (mannitol) Inhalation Powder to Improve Pulmonary Function in Adult Patients with Cystic Fibrosis
• Bronchitol (mannitol) FDA Approval History

Sesquient (fosphenytoin sodium) for Injection

Date of Approval: November 5, 2020
Company: Sedor Pharmaceuticals, LLC
Treatment for: Status Epilepticus

Sesquient (fosphenytoin sodium for injection) is a Captisol-enabled™, room-temperature stable formulation of fosphenytoin sodium indicated for the treatment of status epilepticus in adults and children.

• FDA Approves Sesquient (fosphenytoin sodium) for the Treatment of Status Epilepticus in Adult and Pediatric Patients
• Sesquient (fosphenytoin sodium) FDA Approval History

Sutab (sodium sulfate, magnesium sulfate, and potassium chloride) Tablets

Date of Approval: November 10, 2020
Company: Sebela Pharmaceuticals, Inc.
Treatment for: Bowel Preparation

Sutab (sodium sulfate, magnesium sulfate, and potassium chloride) is an osmotic laxative in a tablet formulation indicated for cleansing the colon in preparation for colonoscopy in adults.

• FDA Approves Sutab (sodium sulfate, magnesium sulfate, and potassium chloride) Tablets for Colonoscopy Preparation
• Sutab (sodium sulfate, magnesium sulfate, and potassium chloride) FDA Approval History

Zokinvy (lonafarnib) Capsules

Date of Approval: November 20, 2020
Company: Eiger BioPharmaceuticals, Inc.
Treatment for: Progeria and Progeroid Laminopathies

Zokinvy (lonafarnib) is an oral farnesyltransferase inhibitor (FTI) for the treatment of Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) and processing-deficient Progeroid Laminopathies (PL).

• FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies
• Zokinvy (lonafarnib) FDA Approval History

Oxlumo (lumasiran) Injection

Date of Approval: November 23, 2020
Company: Alnylam Pharmaceuticals, Inc.
Treatment for: Primary Hyperoxaluria

Oxlumo (lumasiran) is a HAO1-directed small interfering ribonucleic acid (siRNA) indicated for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary and plasma oxalate levels in pediatric and adult patients.

• FDA Approves Oxlumo (lumasiran) for the Treatment of Primary Hyperoxaluria Type 1
• Oxlumo (lumasiran) FDA Approval History

Danyelza (naxitamab-gqgk) Injection

Date of Approval: November 25, 2020
Company: Y-mAbs Therapeutics, Inc.
Treatment for: Neuroblastoma

Danyelza (naxitamab-gqgk) is a GD2-binding monoclonal antibody indicated, in combination with granulocyte-macrophage colony-stimulating factor (GMCSF), for the treatment of patients with relapsed or refractory high-risk neuroblastoma.

• FDA Approves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma
• Danyelza (naxitamab-gqgk) FDA Approval History

Imcivree (setmelanotide) Injection

Date of Approval: November 25, 2020
Company: Rhythm Pharmaceuticals, Inc.
Treatment for: Weight Loss (Obesity/Overweight)

Imcivree (setmelanotide) is a melanocortin 4 (MC4) receptor agonist for chronic weight management of obesity caused by proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency; or Bardet-Biedl syndrome.

• FDA Approves Imcivree (setmelanotide) for Chronic Weight Management in Patients with Obesity Due to POMC, PCSK1 or LEPR Deficiency
• Imcivree (setmelanotide) FDA Approval History

Ga 68 PSMA-11 () Injection

Date of Approval: December 1, 2020
Company: University of California, San Francisco
Treatment for: Diagnosis and Investigation

Ga 68 PSMA-11 Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer.

• FDA Approves Gallium 68 PSMA-11 as the First PSMA-Targeted PET Imaging Drug for Men with Prostate Cancer
• Ga 68 PSMA-11 FDA Approval History

Orladeyo (berotralstat) Capsules

Date of Approval: December 3, 2020
Company: BioCryst Pharmaceuticals, Inc.
Treatment for: Hereditary Angioedema

Orladeyo (berotralstat) is a plasma kallikrein inhibitor indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years and older.

• FDA Approves Orladeyo (berotralstat) as the First Oral, Once-Daily Therapy to Prevent Attacks in Hereditary Angioedema Patients
• Orladeyo (berotralstat) FDA Approval History

Klisyri (tirbanibulin) Ointment

Date of Approval: December 14, 2020
Company: Athenex, Inc.
Treatment for: Actinic Keratosis

Klisyri (tirbanibulin) is a first-in-class dual Src Kinase and tubulin polymerization inhibitor for the topical treatment of actinic keratosis on the face or scalp.

• FDA Approves Klisyri (tirbanibulin) for the Treatment of Actinic Keratosis on the Face or Scalp
• Klisyri (tirbanibulin) FDA Approval History

Margenza (margetuximab-cmkb) Injection

Date of Approval: December 16, 2020
Company: MacroGenics, Inc.
Treatment for: Breast Cancer

Margenza (margetuximab-cmkb) is a HER2/neu receptor antagonist indicated, in combination with chemotherapy, for the treatment of adult patients with metastatic HER2- positive breast cancer.

• FDA Approves Margenza (margetuximab-cmkb) for Patients with Pretreated Metastatic HER2-Positive Breast Cancer
• Margenza (margetuximab-cmkb) FDA Approval History

Riabni (rituximab-arrx) Injection

Date of Approval: December 17, 2020
Company: Amgen
Treatment for: Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, Granulomatosis with Polyangiitis, Microscopic Polyangiitis, Rheumatoid Arthritis

Riabni (rituximab-arrx) is a CD20-directed cytolytic antibody biosimilar to Rituxan indicated for the treatment of adult patients with non-Hodgkin’s Lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis, and granulomatosis with polyangiitis (GPA) (Wegener’s Granulomatosis) and microscopic polyangiitis (MPA).

• FDA Approves Riabni (rituximab-arrx), a Biosimilar to Rituxan
• Riabni (rituximab-arrx) FDA Approval History

Orgovyx (relugolix) Tablets

Date of Approval: December 18, 2020
Company: Myovant Sciences
Treatment for: Prostate Cancer

Orgovyx (relugolix) is an oral gonadotropin-releasing hormone (GnRH) receptor antagonist indicated for the treatment of adult patients with advanced prostate cancer.

• FDA Approves Orgovyx (relugolix) as the First Oral Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist for Advanced Prostate Cancer
• Orgovyx (relugolix) FDA Approval History

Ebanga (ansuvimab-zykl) Injection

Date of Approval: December 21, 2020
Company: Ridgeback Biotherapeutics, LP.
Treatment for: Zaire Ebolavirus Infection

Ebanga (ansuvimab-zykl) is a monoclonal antibody for the treatment of Zaire ebolavirus (Ebolavirus) infection in adults and children.

• FDA Approves Ebanga (ansuvimab-zykl) for the Treatment of Zaire Ebolavirus Infection
• Ebanga (ansuvimab-zykl) FDA Approval History

Gemtesa (vibegron) Tablets

Date of Approval: December 23, 2020
Company: Urovant Sciences
Treatment for: Overactive Bladder

Gemtesa (vibegron) is a once-daily beta-3 adrenergic agonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults.

• FDA Approves Gemtesa (vibegron) Tablets for the Treatment of Patients with Overactive Bladder (OAB)
• Gemtesa (vibegron) FDA Approval History

Thyquidity (levothyroxine sodium) Oral Solution

Date of Approval: November 30, 2020
Company: Vertice Pharma

Thyquidity (levothyroxine sodium) is a liquid dosage form of levothyroxine for the treatment of hypothyroidism.

• Vertice Launches Thyquidity (levothyroxine sodium) Oral Solution
• Thyquidity (levothyroxine sodium) FDA Approval History