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New Drug Approvals Archive for 2020

See also: New Indications and Dosage Forms 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 kinase inhibitor for the treatment of PDGFRα exon 18 mutant gastrointestinal stromal tumors (GIST), and advanced systemic mastocytosis (AdvSM).

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.

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.

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).

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).

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.

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.

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.

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.

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.

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.

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.

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.

Nexletol (bempedoic acid) Tablets

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

Nexletol (bempedoic acid) is a first-in-class, adenosine triphosphate-citrate lyase (ACL) inhibitor for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-Cholesterol.

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.

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.

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 indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C.

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).

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.

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.

Sarclisa (isatuximab-irfc) Injection

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

Sarclisa (isatuximab-irfc) is a CD38-directed cytolytic antibody indicated:
  • 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.

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.

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).

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.

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.

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).

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).

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).

Tukysa (tucatinib) Tablets

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

Tukysa (tucatinib) is a kinase inhibitor indicated in combination with trastuzumab and capecitabine for the treatment of patients with advanced unresectable or metastatic HER2-positive breast cancer.

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.

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.

Trodelvy (sacituzumab govitecan-hziy) Injection

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

Trodelvy (sacituzumab govitecan-hziy) is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of metastatic triple-negative breast cancer (mTNBC) and metastatic urothelial cancer (mUC).

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

Date of Approval: April 23, 2020
Company: Sanofi
Treatment for: Meningococcal Meningitis 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.

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.

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.

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.

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.

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.

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.

Retevmo (selpercatinib) Capsules

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

Retevmo (selpercatinib) is a kinase inhibitor for the treatment of patients with advanced RET fusion-positive non-small cell lung cancer (NSCLC), RET-mutant medullary thyroid cancer (MTC) and RET fusion-positive thyroid cancer.

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.

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).

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.

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.

(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.

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).

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.

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.

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.

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.

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.

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 adults with diabetes mellitus.

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.

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.

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.

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.

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.

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).

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.

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.

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.

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).

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, Maintenance, Ulcerative Colitis, Plaque Psoriasis

Hulio (adalimumab-fkjp) is a tumor necrosis factor (TNF) blocker biosimilar to Humira indicated for the treatment of rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), Crohn’s disease (CD), ulcerative colitis (UC), and plaque psoriasis (Ps).

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.

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.

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.

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).

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).

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.

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).

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.

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.

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.

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.

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.

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.

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.

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.

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.

Sogroya (somapacitan-beco) Injection

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

Sogroya (somapacitan-beco) is a human growth hormone analog indicated for the replacement of endogenous growth hormone in adults with growth hormone deficiency.

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.

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.

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 for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion- positive non-small cell lung cancer (NSCLC), and adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC).

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.

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.

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.

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.

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.

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.

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.

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.

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.

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).

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 oxalate levels in pediatric and adult patients.

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.

Imcivree (setmelanotide) Injection

Date of Approval: November 25, 2020
Company: Rhythm Pharmaceuticals, Inc.
Treatment for: Obesity

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.

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.

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.

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.

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.

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).

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.

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.

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.

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.

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