New Drug Approvals Archive for 2019

Ontruzant (trastuzumab-dttb) for Injection

Date of Approval: January 18, 2019
Company: Organon Pharmaceuticals
Treatment for: Breast Cancer, Gastric Cancer

Ontruzant (trastuzumab-dttb) is a HER2/neu receptor antagonist biosimilar to Herceptin indicated for the treatment of HER2-overexpressing breast cancer, and the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

• FDA Approves Ontruzant (trastuzumab-dttb), a Biosimilar to Herceptin
• Ontruzant (trastuzumab-dttb) FDA Approval History

Tosymra (sumatriptan) Nasal Spray

Date of Approval: January 25, 2019
Company: Dr. Reddy's Laboratories, Inc.
Treatment for: Migraine

Tosymra (sumatriptan) is a serotonin (5-HT1B/1D) receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults.

• FDA Approves Tosymra (sumatriptan) Nasal Spray for Acute Treatment of Migraine
• Tosymra (sumatriptan) FDA Approval History

Wixela Inhub (fluticasone propionate and salmeterol) Inhalation Powder

Date of Approval: January 30, 2019
Company: Mylan N.V.
Treatment for: Asthma, COPD

Wixela Inhub is the first approved generic version of Advair Diskus.

• FDA Approves Wixela Inhub (fluticasone propionate and salmeterol inhalation powder, USP), First Generic of Advair Diskus
• Wixela Inhub (fluticasone propionate and salmeterol) FDA Approval History

Jeuveau (prabotulinumtoxinA-xvfs) Injection

Date of Approval: February 1, 2019
Company: Evolus, Inc.
Treatment for: Glabellar Lines

Jeuveau (prabotulinumtoxinA) is a proprietary 900 kDa purified botulinum toxin type A formulation for the temporary improvement in the appearance of moderate to severe glabellar (frown) lines.

• FDA Approves Jeuveau (prabotulinumtoxinA-xvfs) for Temporary Improvement in the Appearance of Frown Lines
• Jeuveau (prabotulinumtoxinA-xvfs) FDA Approval History

Cablivi (caplacizumab-yhdp) Injection

Date of Approval: February 6, 2019
Company: Ablynx NV
Treatment for: Acquired Thrombotic Thrombocytopenic Purpura

Cablivi (caplacizumab-yhdp) is a von Willebrand factor (vWF)-directed antibody fragment indicated for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy.

• FDA Approves Cablivi (caplacizumab-yhdp) for Acquired Thrombotic Thrombocytopenic Purpura (aTTP) in Adults
• Cablivi (caplacizumab-yhdp) FDA Approval History

Egaten (triclabendazole) Tablets

Date of Approval: February 13, 2019
Company: Novartis
Treatment for: Fascioliasis

Egaten (triclabendazole) is a benzimidazole anthelmintic indicated for the treatment of fascioliasis, a neglected tropical disease (NTD) caused by liver flukes Fasciola hepatica and Fasciola gigantica.

• FDA Approves Egaten (triclabendazole) for the Treatment of Fascioliasis, a Neglected Tropical Disease
• Egaten (triclabendazole) FDA Approval History

Esperoct (antihemophilic factor (recombinant) glycopegylated-exei) Injection

Date of Approval: February 19, 2019
Company: Novo Nordisk
Treatment for: Hemophilia A

Esperoct (antihemophilic factor [recombinant] glycopegylated-exei) is an extended half-life factor VIII molecule that may be used to treat or prevent bleeding episodes in adults and children with hemophilia A.

• FDA Approves Esperoct (turoctocog alfa pegol, N8-GP) for Hemophilia A
• Esperoct (antihemophilic factor (recombinant) glycopegylated-exei) FDA Approval History

Gloperba (colchicine) Oral Solution

Date of Approval: January 30, 2019
Company: Romeg Therapeutics, LLC
Treatment for: Gout

Gloperba (colchicine) is an oral solution formulation of the approved drug colchicine indicated for prophylaxis of gout flares in adults.

• FDA Approves Gloperba (colchicine) for Prophylaxis of Adult Gout Flares
• Gloperba (colchicine) FDA Approval History

Herceptin Hylecta (trastuzumab and hyaluronidase-oysk) for Subcutaneous Injection

Date of Approval: February 28, 2019
Company: Genentech, Inc.
Treatment for: Breast Cancer

Herceptin Hylecta (trastuzumab and hyaluronidase-oysk) is a combination of the approved HER2/neu receptor antagonist trastuzumab (Herceptin) and recombinant human hyaluronidase PH20 (an enzyme that helps to deliver trastuzumab under the skin) indicated for the treatment of HER2-overexpressing breast cancer.

• FDA Approves Herceptin Hylecta for Subcutaneous Injection in Certain HER2-Positive Breast Cancers
• Herceptin Hylecta (trastuzumab and hyaluronidase-oysk) FDA Approval History

Adhansia XR (methylphenidate hydrochloride) Extended-Release Capsules

Date of Approval: February 27, 2019
Company: Purdue Pharma L.P.
Treatment for: ADHD

Adhansia XR (methylphenidate hydrochloride) is an extended-release capsule formulation of the approved central nervous system (CNS) stimulant methylphenidate indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in patients six years and older.

• FDA Approves Adhansia XR (methylphenidate hydrochloride) Extended-Release Capsules for the Treatment of ADHD
• Adhansia XR (methylphenidate hydrochloride) FDA Approval History

Spravato (esketamine) Nasal Spray

Date of Approval: March 5, 2019
Company: Janssen Pharmaceuticals, Inc.
Treatment for: Depression, Major Depressive Disorder with Acute Suicidal Ideation

Spravato (esketamine) is a rapid acting, nasal spray formulation of a non-competitive N-methyl D-aspartate (NMDA) receptor antagonist for the treatment of treatment-resistant depression (TRD) and depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior.

• FDA Approves Spravato (esketamine) Nasal Spray for Treatment-Resistant Depression
• Spravato (esketamine) FDA Approval History

Trazimera (trastuzumab-qyyp) for Injection

Date of Approval: March 11, 2019
Company: Pfizer Inc.
Treatment for: Breast Cancer, Gastric Cancer

Trazimera (trastuzumab-qyyp) is a HER2/neu receptor antagonist biosimilar to Herceptin indicated for the treatment of HER2-overexpressing breast cancer, and the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

• FDA Approves Trazimera (trastuzumab-qyyp), a Biosimilar to Herceptin
• Trazimera (trastuzumab-qyyp) FDA Approval History

Rocklatan (netarsudil and latanoprost) Ophthalmic Solution

Date of Approval: March 12, 2019
Company: Aerie Pharmaceuticals, Inc.
Treatment for: Glaucoma, Open Angle, Intraocular Hypertension

Rocklatan (netarsudil and latanoprost ophthalmic solution) is a fixed dose combination of the Rho kinase inhibitor netarsudil (Rhopressa) and the prostaglandin F2α analogue latanoprost (Xalatan), indicated to reduce elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

• FDA Approves Rocklatan (netarsudil and latanoprost ophthalmic solution) for the Reduction of Intraocular Pressure in Open-Angle Glaucoma or Ocular Hypertension
• Rocklatan (netarsudil and latanoprost) FDA Approval History

Zulresso (brexanolone) Injection

Date of Approval: March 19, 2019
Company: Sage Therapeutics
Treatment for: Postpartum Depression

Zulresso (brexanolone) is a gamma-aminobutyric acid A (GABA_A) receptor positive allosteric modulator indicated for the treatment of postpartum depression (PPD).

• FDA Approves Zulresso (brexanolone) for the Treatment of Postpartum Depression
• Zulresso (brexanolone) FDA Approval History

Sunosi (solriamfetol) Tablets

Date of Approval: March 20, 2019
Company: Jazz Pharmaceuticals plc
Treatment for: Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome

Sunosi (solriamfetol) is a selective dopamine and norepinephrine reuptake inhibitor (DNRI) for the treatment of excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea (OSA).

• FDA Approves Sunosi (solriamfetol) for Excessive Daytime Sleepiness Associated with Narcolepsy or Obstructive Sleep Apnea
• Sunosi (solriamfetol) FDA Approval History

Mayzent (siponimod) Tablets

Date of Approval: March 26, 2019
Company: Novartis
Treatment for: Multiple Sclerosis

Mayzent (siponimod) is a sphingosine-1-phosphate receptor modulator 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 Mayzent (siponimod) for Secondary Progressive Multiple Sclerosis
• Mayzent (siponimod) FDA Approval History

Jatenzo (testosterone undecanoate) Capsules

Date of Approval: March 27, 2019
Company: Clarus Therapeutics, Inc.
Treatment for: Hypogonadism, Male

Jatenzo (testosterone undecanoate) is an oral testosterone replacement therapy for the treatment of low testosterone in hypogonadal men.

• FDA Approves Jatenzo (testosterone undecanoate) for Certain Forms of Hypogonadism
• Jatenzo (testosterone undecanoate) FDA Approval History

Mavenclad (cladribine) Tablets

Date of Approval: March 29, 2019
Company: EMD Serono, Inc.
Treatment for: Multiple Sclerosis

Mavenclad (cladribine) is a purine antimetabolite indicated for the treatment of relapsing forms of multiple sclerosis (MS).

• FDA Approves Mavenclad (cladribine) Tablets for Multiple Sclerosis
• Mavenclad (cladribine) FDA Approval History

Duaklir Pressair (aclidinium bromide and formoterol fumarate) Inhalation Powder

Date of Approval: March 29, 2019
Company: Circassia Pharmaceuticals plc
Treatment for: COPD

Duaklir Pressair (aclidinium bromide and formoterol fumarate) is a long-acting muscarinic antagonist (LAMA) and long-acting beta₂ agonist (LABA) fixed dose combination maintenance bronchodilator for the treatment of COPD.

• FDA Approves Duaklir Pressair (aclidinium bromide and formoterol fumarate) for Maintenance Treatment of Chronic Obstructive Pulmonary Disease
• Duaklir Pressair (aclidinium bromide and formoterol fumarate) FDA Approval History

Asceniv (immune globulin intravenous, human – slra) Injection

Date of Approval: April 1, 2019
Company: ADMA Biologics, Inc.
Treatment for: Primary Immunodeficiency Syndrome

Asceniv (immune globulin intravenous, human – slra) is a 10% immune globulin liquid for intravenous injection, indicated for the treatment of primary humoral immunodeficiency (PI).

• FDA Approves Asceniv (immune globulin intravenous, human) for Primary Humoral Immunodeficiency
• Asceniv (immune globulin intravenous, human – slra) FDA Approval History

Avaclyr (acyclovir) Ophthalmic Ointment

Date of Approval: March 29, 2019
Company: Fera Pharmaceuticals
Treatment for: Herpes Simplex Dendritic Keratitis

Avaclyr (acyclovir ophthalmic ointment) is a herpes simplex virus nucleoside analog DNA polymerase inhibitor indicated for the treatment of acute herpetic keratitis (dendritic ulcers) in patients with herpes simplex (HSV-1 and HSV-2) virus.

• FDA Approves Avaclyr (acyclovir ophthalmic ointment) for the Treatment of Herpetic Keratitis
• Avaclyr (acyclovir) FDA Approval History

Dovato (dolutegravir and lamivudine) Tablets

Date of Approval: April 8, 2019
Company: ViiV Healthcare
Treatment for: HIV Infection

Dovato (dolutegravir and lamivudine) is an integrase strand transfer inhibitor and nucleoside analogue reverse transcriptase inhibitor combination used for the treatment of HIV-1 infection.

• FDA Approves Dovato (dolutegravir/lamivudine) for HIV-1 Infection in Adults with No Antiretroviral (ARV) Treatment History
• Dovato (dolutegravir and lamivudine) FDA Approval History

Evenity (romosozumab-aqqg) Injection

Date of Approval: April 9, 2019
Company: Amgen Inc.
Treatment for: Osteoporosis

Evenity (romosozumab) is an anti-sclerostin monoclonal antibody for the treatment of osteoporosis in postmenopausal women at increased risk of fracture.

• FDA Approves Evenity (romosozumab-aqqg) for the Treatment of Osteoporosis in Postmenopausal Women at High Risk of Fracture
• Evenity (romosozumab-aqqg) FDA Approval History

Balversa (erdafitinib) Tablets

Date of Approval: April 12, 2019
Company: Janssen Pharmaceuticals, Inc.
Treatment for: Urothelial Carcinoma

Balversa (erdafitinib) is a pan-fibroblast growth factor receptor (FGFR) inhibitor for the treatment of patients with locally advanced or metastatic urothelial cancer (mUC) with susceptible FGFR3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy.

• FDA Approves Balversa (erdafitinib) for the Treatment of Metastatic Bladder Cancer
• Balversa (erdafitinib) FDA Approval History

Plenity (cellulose and citric acid) Capsules

Date of Approval: April 12, 2019
Company: Gelesis
Treatment for: Weight Loss (Obesity/Overweight)

Plenity (cellulose and citric acid) is an oral, non-systemic, superabsorbent hydrogel used in conjunction with diet and exercise to aid weight management in adults who are overweight or obese. It works by inducing a feeling of fullness so that patients eat less and lose weight.

• Gelesis Granted FDA Clearance to Market Plenity - a New Prescription Aid in Weight Management
• Plenity (cellulose and citric acid) FDA Approval History

Skyrizi (risankizumab-rzaa) Injection

Date of Approval: April 23, 2019
Company: AbbVie Inc.
Treatment for: Plaque Psoriasis, Psoriatic Arthritis, Crohn's Disease, Ulcerative Colitis

Skyrizi (risankizumab-rzaa) is an interleukin-23 (IL-23) inhibitor for the treatment of plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.

• FDA Approves Skyrizi (risankizumab-rzaa) for Moderate to Severe Plaque Psoriasis
• Skyrizi (risankizumab-rzaa) FDA Approval History

Duobrii (halobetasol propionate and tazarotene) Lotion

Date of Approval: April 25, 2019
Company: Ortho Dermatologics
Treatment for: Plaque Psoriasis

Duobrii (halobetasol propionate and tazarotene) is a corticosteroid and retinoid combination indicated for the topical treatment of plaque psoriasis.

• FDA Approves Duobrii (halobetasol propionate and tazarotene) Lotion 0.01%/0.045% for Plaque Psoriasis In Adults
• Duobrii (halobetasol propionate and tazarotene) FDA Approval History

Eticovo (etanercept-ykro) Injection

Date of Approval: April 25, 2019
Company: Samsung Bioepis Co., Ltd.

Eticovo (etanercept-ykro) is a tumor necrosis factor (TNF) blocker biosimilar to Enbrel indicated for the treatment of rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis.

• FDA Approves Eticovo (etanercept-ykro), a Biosimilar to Enbrel
• Eticovo (etanercept-ykro) FDA Approval History

Dengvaxia (dengue tetravalent vaccine, live) Injection

Date of Approval: May 1, 2019
Company: Sanofi Pasteur, Inc.
Treatment for: Prevention of Dengue Disease

Dengvaxia (dengue tetravalent vaccine, live) is a vaccine indicated for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4 in individuals 6 through 16 years of age with laboratory-confirmed previous dengue infection and living in endemic areas.

• FDA Approves Dengvaxia (dengue vaccine) for the Prevention of Dengue Disease in Endemic Regions
• Dengvaxia (dengue tetravalent vaccine, live) FDA Approval History

Qternmet XR (dapagliflozin, metformin hydrochloride and saxagliptin) Extended-Release Tablets

Date of Approval: May 2, 2019
Company: AstraZeneca
Treatment for: Type 2 Diabetes

Qternmet XR (dapagliflozin, metformin hydrochloride and saxagliptin) is a sodium-glucose cotransporter 2 (SGLT2) inhibitor, biguanide and dipeptidyl peptidase-4 (DPP-4) inhibitor combination indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

• FDA Approves Qternmet XR (dapagliflozin, saxagliptin and metformin hydrochloride) for Type 2 Diabetes
• Qternmet XR (dapagliflozin, metformin hydrochloride and saxagliptin) FDA Approval History

Vyndaqel (tafamidis meglumine) Capsules

Date of Approval: May 3, 2019
Company: Pfizer Inc.
Treatment for: Cardiomyopathy of Transthyretin-Mediated Amyloidosis

Vyndaqel (tafamidis meglumine) is a transthyretin stabilizer indicated for the treatment of the cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis.

• FDA Approves New Treatments Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) for Heart Disease Caused by Transthyretin Mediated Amyloidosis
• Vyndaqel (tafamidis meglumine) FDA Approval History

Ruzurgi (amifampridine) Tablets

Date of Approval: May 6, 2019
Company: Jacobus Pharmaceutical Company, Inc.
Treatment for: Lambert-Eaton Myasthenic Syndrome

Ruzurgi (amifampridine) is a potassium-channel blocker indicated for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in patients 6 years to less than 17 years of age.

• FDA Approves Ruzurgi (amifampridine) for Children with Lambert-Eaton Myasthenic Syndrome
• Ruzurgi (amifampridine) FDA Approval History

Nayzilam (midazolam) Nasal Spray

Date of Approval: May 17, 2019
Company: UCB
Treatment for: Seizure Clusters

Nayzilam (midazolam) is a nasally administered benzodiazepine indicated for the acute treatment of seizure clusters.

• FDA Approves Nayzilam (midazolam) Nasal Spray to Treat Seizure Clusters
• Nayzilam (midazolam) FDA Approval History

Piqray (alpelisib) Tablets

Date of Approval: May 24, 2019
Company: Novartis
Treatment for: Breast Cancer

Piqray (alpelisib) is a kinase inhibitor indicated in combination with fulvestrant for the treatment of postmenopausal women, and men, with HR positive, HER2-negative, PIK3CA-mutated breast cancer.

• FDA Approves Piqray (alpelisib) as First PI3K Inhibitor for Breast Cancer
• Piqray (alpelisib) FDA Approval History

Zolgensma (onasemnogene abeparvovec-xioi) Suspension for Intravenous Infusion

Date of Approval: May 24, 2019
Company: Novartis
Treatment for: Spinal Muscular Atrophy

Zolgensma (onasemnogene abeparvovec-xioi) is an adeno-associated virus vector-based gene therapy indicated for the treatment of pediatric patients less than 2 years of age with spinal muscular atrophy (SMA).

• FDA Approves Zolgensma (onasemnogene abeparvovec-xioi) Gene Therapy to Treat Pediatric Patients with Spinal Muscular Atrophy
• Zolgensma (onasemnogene abeparvovec-xioi) FDA Approval History

Slynd (drospirenone) Tablets

Date of Approval: May 23, 2019
Company: Exeltis
Treatment for: Birth Control

Slynd (drospirenone) is a progestin oral contraceptive for birth control.

• Exeltis USA, Inc. Announces the Approval of Slynd (drospirenone), the First and Only Progestin-Only Pill Providing Pregnancy Prevention with a 24/4 Dosing Regimen and 24-hour Missed Pill Window
• Slynd (drospirenone) FDA Approval History

Polivy (polatuzumab vedotin-piiq) Injection

Date of Approval: June 10, 2019
Company: Genentech, Inc.
Treatment for: Diffuse Large B-Cell Lymphoma

Polivy (polatuzumab vedotin-piiq) is a CD79b-directed antibody and microtubule inhibitor conjugate used for the treatment of diffuse large B-cell lymphoma.

• FDA Grants Genentech’s Polivy (polatuzumab vedotin-piiq) Accelerated Approval for Adults With Previously Treated Aggressive Lymphoma
• Polivy (polatuzumab vedotin-piiq) FDA Approval History

Kanjinti (trastuzumab-anns) Injection

Date of Approval: June 13, 2019
Company: Amgen Inc.
Treatment for: Breast Cancer, Gastric Cancer

Kanjinti (trastuzumab-anns) is a HER2/neu receptor antagonist biosimilar to Herceptin indicated for the treatment of HER2 overexpressing breast cancer, and the treatment of HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

• FDA Approves Kanjinti (trastuzumab-anns), a Biosimilar to Herceptin
• Kanjinti (trastuzumab-anns) FDA Approval History

Vyleesi (bremelanotide) Injection

Date of Approval: June 21, 2019
Company: Cosette Pharmaceuticals, Inc.
Treatment for: Hypoactive Sexual Desire Disorder

Vyleesi (bremelanotide) is a melanocortin receptor agonist for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women.

• AMAG Pharmaceuticals Announces FDA Approval of Vyleesi (bremelanotide injection) for Hypoactive Sexual Desire Disorder (HSDD) in Premenopausal Women
• Vyleesi (bremelanotide) FDA Approval History

Zirabev (bevacizumab-bvzr) Injection

Date of Approval: June 27, 2019
Company: Pfizer Inc.
Treatment for: Colorectal Cancer, Non Small Cell Lung Cancer, Glioblastoma Multiforme, Renal Cell Carcinoma, Cervical Cancer, Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer

Zirabev (bevacizumab-bvzr) is a vascular endothelial growth factor (VEGF) inhibitor biosimilar to Avastin (bevacizumab) for the treatment of multiple types of cancer including metastatic colorectal cancer; non-small cell lung cancer; glioblastoma; metastatic renal cell carcinoma; cervical cancer; and epithelial ovarian, fallopian tube, or primary peritoneal cancer.

• FDA Approves Zirabev (bevacizumab-bvzr), a Biosimilar to Avastin
• Zirabev (bevacizumab-bvzr) FDA Approval History

Thiola EC (tiopronin) Delayed-Release Tablets

Date of Approval: June 28, 2019
Company: Retrophin, Inc.
Treatment for: Cystinuria

Thiola EC (tiopronin) is a reducing and complexing thiol indicated for the prevention of cystine stone formation in patients with cystinuria.

• FDA Approves Thiola EC (tiopronin) for the Treatment of Cystinuria
• Thiola EC (tiopronin) FDA Approval History

Xpovio (selinexor) Tablets

Date of Approval: July 3, 2019
Company: Karyopharm Therapeutics Inc.
Treatment for: Multiple Myeloma; Diffuse Large B-cell Lymphoma

Xpovio (selinexor) is a first in class Selective Inhibitor of Nuclear Export (SINE) XPO1 antagonist for the treatment of patients adult patients with multiple myeloma (RRMM) and relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

• FDA Approves Xpovio (selinexor) for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma
• Xpovio (selinexor) FDA Approval History

Xembify (immune globulin subcutaneous, human - klhw) Injection

Date of Approval: July 3, 2019
Company: Grifols
Treatment for: Primary Immunodeficiency Syndrome

Xembify (immune globulin subcutaneous, human- klhw) is a 20% immune globulin solution for subcutaneous injection indicated for treatment of Primary Humoral Immunodeficiency (PI) in patients 2 years of age and older.

• FDA Approves Xembify (immune globulin subcutaneous) for Primary Immunodeficiencies
• Xembify (immune globulin subcutaneous, human - klhw) FDA Approval History

Katerzia (amlodipine benzoate) Oral Suspension

Date of Approval: July 8, 2019
Company: Azurity Pharmaceuticals, Inc.
Treatment for: High Blood Pressure, Coronary Artery Disease

Katerzia (amlodipine benzoate) is a calcium channel blocker in an oral suspension formulation indicated for the treatment of hypertension in adults and pediatric patients 6 years of age and older, and coronary artery disease in adults.

• FDA Approves Katerzia (amlodipine) Oral Suspension for Pediatric Patients 6 Years of Age and Older
• Katerzia (amlodipine benzoate) FDA Approval History

AirDuo Digihaler (fluticasone propionate and salmeterol) Inhalation Powder

Date of Approval: July 15, 2019
Treatment for: Asthma

AirDuo Digihaler (fluticasone propionate and salmeterol) is a corticosteroid and a long-acting beta₂-adrenergic agonist (LABA) combination therapy for the treatment of asthma in patients aged 12 years and older.

• FDA Approves AirDuo Digihaler (fluticasone propionate and salmeterol) Inhalation Powder for Asthma
• AirDuo Digihaler (fluticasone propionate and salmeterol) FDA Approval History

Recarbrio (imipenem, cilastatin, and relebactam) for Injection

Date of Approval: July 16, 2019
Company: Merck
Treatment for: Urinary Tract Infection, Intraabdominal Infection, Nosocomial Pneumonia

Recarbrio (imipenem, cilastatin, and relebactam) is a combination of imipenem, a penem antibacterial, cilastatin, a renal dehydropeptidase inhibitor, and relebactam, a betalactamase inhibitor, indicated for the treatment of complicated urinary tract infections (cUTI), complicated intra-abdominal infections (cIAI), and hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in adults.

• FDA Approves Recarbrio (imipenem, cilastatin, and relebactam) for the Treatment of Complicated Urinary Tract and Complicated Intra-Abdominal Bacterial Infections
• Recarbrio (imipenem, cilastatin, and relebactam) FDA Approval History

Myxredlin (insulin human in sodium chloride) Injection

Date of Approval: June 20, 2019
Company: Baxter International Inc.
Treatment for: Diabetes, Type 1, Type 2 Diabetes

Myxredlin (insulin human in sodium chloride) is a short-acting human insulin indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.

• Baxter Announces U.S FDA Approval of Myxredlin, the First and Only Ready-To-Use Insulin for IV Infusion
• Myxredlin (insulin human in sodium chloride) FDA Approval History

Ruxience (rituximab-pvvr) Injection

Date of Approval: July 23, 2019
Company: Pfizer Inc.
Treatment for: Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, Granulomatosis with Polyangiitis, Microscopic Polyangiitis

Ruxience (rituximab-pvvr) 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), and granulomatosis with polyangiitis (GPA) (Wegener’s Granulomatosis) and microscopic polyangiitis (MPA).

• FDA Approves Ruxience (rituximab-pvvr), a Biosimilar to Rituxan
• Ruxience (rituximab-pvvr) FDA Approval History

Hadlima (adalimumab-bwwd) Injection

Date of Approval: July 23, 2019
Company: Organon Pharmaceuticals
Treatment for: Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Crohn's Disease, Ulcerative Colitis, Plaque Psoriasis, Hidradenitis Suppurativa, Uveitis

Hadlima (adalimumab-bwwd) is a tumor necrosis factor (TNF) blocker interchangeable 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 Hadlima (adalimumab-bwwd), a Biosimilar to Humira
• Hadlima (adalimumab-bwwd) FDA Approval History

Baqsimi (glucagon) Nasal Powder

Date of Approval: July 24, 2019
Company: Eli Lilly and Company
Treatment for: Hypoglycemia

Baqsimi (glucagon) is a nasally administered antihypoglycemic agent indicated for the treatment of severe hypoglycemia in adults and pediatric patients aged 1 year and older with diabetes.

• FDA Approves Baqsimi (glucagon) Nasal Powder for the Treatment of Severe Hypoglycemia
• Baqsimi (glucagon) FDA Approval History

Accrufer (ferric maltol) Capsules - formerly Feraccru

Date of Approval: July 25, 2019
Company: Shield Therapeutics plc
Treatment for: Iron Deficiency

Accrufer (ferric maltol) is a non-salt formulation of ferric iron for the treatment of iron deficiency in adults.

• FDA Approves Accrufer (ferric maltol) for the Treatment of Iron Deficiency in Adults
• Accrufer (ferric maltol) FDA Approval History

Nubeqa (darolutamide) Tablets

Date of Approval: July 30, 2019
Company: Bayer
Treatment for: Prostate Cancer

Nubeqa (darolutamide) is an androgen receptor inhibitor (ARi) used in the treatment of prostate cancer.

• FDA Approves Nubeqa (darolutamide) for Men with Non-Metastatic Castration-Resistant Prostate Cancer
• Nubeqa (darolutamide) FDA Approval History

Turalio (pexidartinib) Capsules

Date of Approval: August 2, 2019
Company: Daiichi Sankyo Company, Limited
Treatment for: Tenosynovial Giant Cell Tumor

Turalio (pexidartinib) is a kinase inhibitor indicated for the treatment of symptomatic tenosynovial giant cell tumor (TGCT) in adults.

• FDA Approves Turalio (pexidartinib) for the Treatment of Symptomatic Tenosynovial Giant Cell Tumors (TGCT) in Adults
• Turalio (pexidartinib) FDA Approval History

(pretomanid) Tablets

Date of Approval: August 14, 2019
Company: TB Alliance
Treatment for: Tuberculosis, Resistant

Pretomanid is a nitroimidazooxazine antimycobacterial indicated for use in combination with bedaquiline and linezolid (the BPaL regimen) for the treatment of adults with pulmonary extensively drug resistant (XDR), treatment-intolerant or nonresponsive multidrug-resistant (MDR) tuberculosis (TB).

• FDA Approves Pretomanid for Highly Drug-Resistant Forms of Tuberculosis
• pretomanid FDA Approval History

Rozlytrek (entrectinib) Capsules and Oral Pellets

Date of Approval: August 15, 2019
Company: Genentech, Inc.
Treatment for: Solid Tumors, Non Small Cell Lung Cancer

Rozlytrek (entrectinib) is a selective tyrosine kinase inhibitor for the treatment of patients with ROS1-positive, metastatic non-small cell lung cancer and neurotrophic tyrosine receptor kinase (NTRK) gene fusion-positive solid tumors.

• FDA Approves Rozlytrek (entrectinib) for People With ROS1-Positive, Metastatic Non-Small Cell Lung Cancer and NTRK Gene Fusion-Positive Solid Tumors
• Rozlytrek (entrectinib) FDA Approval History

Wakix (pitolisant) Tablets

Date of Approval: August 14, 2019
Company: Harmony Biosciences, LLC
Treatment for: Narcolepsy

Wakix (pitolisant) is a histamine-3 (H₃) receptor antagonist/inverse agonist for the treatment of narcolepsy.

• FDA Approves Wakix (pitolisant), a First-in-Class Medication for the Treatment of Excessive Daytime Sleepiness in Adult Patients with Narcolepsy
• Wakix (pitolisant) FDA Approval History

Inrebic (fedratinib) Capsules

Date of Approval: August 16, 2019
Company: Celgene Corporation
Treatment for: Myelofibrosis

Inrebic (fedratinib) is a highly selective JAK2 inhibitor for the treatment of patients with myelofibrosis.

• FDA Approves Inrebic (fedratinib) for the Treatment of Patients With Myelofibrosis
• Inrebic (fedratinib) FDA Approval History

Rinvoq (upadacitinib) Extended-Release Tablets

Date of Approval: August 16, 2019
Company: AbbVie Inc.
Treatment for: Rheumatoid Arthritis, Psoriatic Arthritis, Atopic Dermatitis, Ulcerative Colitis, Crohn's Disease, Ankylosing Spondylitis, Non-Radiographic Axial Spondyloarthritis, Polyarticular Juvenile Idiopathic Arthritis, Giant Cell Arteritis

Rinvoq (upadacitinib) is a Janus kinase (JAK) inhibitor for the treatment of rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, ulcerative colitis, Crohn’s disease, ankylosing spondylitis, non-radiographic axial spondyloarthritis, polyarticular juvenile idiopathic arthritis, and giant cell arteritis.

• FDA Approves Rinvoq (upadacitinib), an Oral JAK Inhibitor for the Treatment of Moderate to Severe Rheumatoid Arthritis
• Rinvoq (upadacitinib) FDA Approval History

Xenleta (lefamulin) Tablets and Injection

Date of Approval: August 19, 2019
Company: Nabriva Therapeutics plc
Treatment for: Pneumonia

Xenleta (lefamulin) is a first-in-class, semi-synthetic pleuromutilin antibiotic for the treatment of community-acquired bacterial pneumonia (CABP).

• FDA Approves Xenleta (lefamulin) to Treat Community-Acquired Bacterial Pneumonia (CABP)
• Xenleta (lefamulin) FDA Approval History

Nourianz (istradefylline) Tablets

Date of Approval: August 27, 2019
Company: Kyowa Kirin, Inc.
Treatment for: Parkinson's Disease

Nourianz (istradefylline) is an adenosine A_2A receptor antagonist indicated for use as an adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson’s disease (PD) experiencing “OFF” episodes.

• FDA Approves Nourianz (istradefylline) as an Add-On Drug to Treat Off Episodes in Adults with Parkinson’s Disease
• Nourianz (istradefylline) FDA Approval History

Gvoke (glucagon) Injection

Date of Approval: September 10, 2019
Company: Xeris Pharmaceuticals, Inc.
Treatment for: Hypoglycemia, Diagnosis and Investigation

Gvoke (glucagon injection) is a ready-to-use, room-temperature stable, liquid glucagon for the treatment of hypoglycemia. Gvoke VialDx (glucagon injection) is used as a diagnostic aid.

• FDA Approves Gvoke (glucagon), the First Ready-to-use Stable Liquid Glucagon for Severe Hypoglycemia
• Gvoke (glucagon) FDA Approval History

Ibsrela (tenapanor) Tablets

Date of Approval: September 12, 2019
Company: Ardelyx, Inc
Treatment for: Irritable Bowel Syndrome

Ibsrela (tenapanor) is a first-in-class, sodium/hydrogen exchanger 3 (NHE3) inhibitor indicated for the treatment of adults with irritable bowel syndrome with constipation (IBS-C).

• FDA Approves Ibsrela (tenapanor) for the Treatment of Irritable Bowel Syndrome with Constipation
• Ibsrela (tenapanor) FDA Approval History

Rybelsus (semaglutide) Tablets

Date of Approval: September 20, 2019
Company: Novo Nordisk
Treatment for: Type 2 Diabetes

Rybelsus (semaglutide) is an oral glucagon-like peptide-1 (GLP-1) receptor agonist indicated for the treatment of adults with type 2 diabetes mellitus.

• FDA Approves Rybelsus (semaglutide), the First Oral GLP-1 Analog Treatment for Adults with Type 2 Diabetes
• Rybelsus (semaglutide) FDA Approval History

Jynneos (smallpox and mpox vaccine) Injection

Date of Approval: September 24, 2019
Company: Bavarian Nordic A/S
Treatment for: Mpox, Smallpox Prophylaxis

Jynneos (smallpox and mpox vaccine, live, non-replicating) is a vaccine for the prevention of smallpox and mpox disease.

• FDA Approves Jynneos (Smallpox and Monkeypox Vaccine, Live, Non-replicating) for Prevention of Smallpox and Monkeypox Disease in Adults
• Jynneos (smallpox and mpox vaccine) FDA Approval History

Aklief (trifarotene) Topical Cream

Date of Approval: October 4, 2019
Company: Galderma
Treatment for: Acne

Aklief (trifarotene) is a topical retinoid indicated for the treatment of acne vulgaris in patients 9 years of age and older.

• FDA Approves Aklief (trifarotene) Cream, a New Topical Retinoid for the Treatment of Acne
• Aklief (trifarotene) FDA Approval History

Bonsity (teriparatide) Injection - formerly PF708

Date of Approval: October 4, 2019
Company: Pfenex Inc.
Treatment for: Osteoporosis

Bonsity (teriparatide) is a parathyroid hormone analog (PTH 1-34) indicated for the treatment of osteoporosis in certain patients at high risk for fracture.

• FDA Approves Bonsity (teriparatide injection) to Treat Osteoporosis
• Bonsity (teriparatide) FDA Approval History

Scenesse (afamelanotide) Implant

Date of Approval: October 8, 2019
Company: Clinuvel Pharmaceuticals Ltd.
Treatment for: Prevention of Phototoxicity in Erythropoietic Protoporphyria

Scenesse (afamelanotide) is a selective agonist of the melanocortin 1 receptor (MC1R) indicated for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP).

• FDA Approves Scenesse (afamelanotide) for Prevention of Phototoxicity in Erythropoietic Protoporphyria
• Scenesse (afamelanotide) FDA Approval History

Beovu (brolucizumab-dbll) Injection

Date of Approval: October 7, 2019
Company: Novartis
Treatment for: Macular Degeneration, Diabetic Macular Edema

Beovu (brolucizumab-dbll) is a human vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD) and diabetic macular edema (DME).

• FDA Approves Beovu (brolucizumab-dbll) for the Treatment of Wet Age-Related Macular Degeneration (AMD)
• Beovu (brolucizumab-dbll) FDA Approval History

Quzyttir (cetirizine hydrochloride) Injection

Date of Approval: October 4, 2019
Company: TerSera Therapeutics LLC
Treatment for: Urticaria

Quzyttir (cetirizine hydrochloride) is a histamine-1 (H1) receptor antagonist indicated for the treatment of acute urticaria in adults and children 6 months of age and older.

• FDA Approves Quzyttir (cetirizine) Injection for the Treatment of Acute Urticaria
• Quzyttir (cetirizine hydrochloride) FDA Approval History

Reyvow (lasmiditan) Tablets

Date of Approval: October 11, 2019
Company: Eli Lilly and Company
Treatment for: Migraine

Reyvow (lasmiditan) is a serotonin (5-HT)_1F receptor agonist indicated for the acute treatment of migraine with or without aura in adults.

• FDA Approves Reyvow (lasmiditan), the First Serotonin (5-HT) 1F Receptor Agonist for the Acute Treatment for Migraine
• Reyvow (lasmiditan) FDA Approval History

Secuado (asenapine) Transdermal System

Date of Approval: October 11, 2019
Company: Noven Pharmaceuticals, Inc.
Treatment for: Schizophrenia

Secuado (asenapine) is a transdermal atypical antipsychotic formulation indicated for the treatment of adults with schizophrenia.

• FDA Approves Secuado (asenapine) Transdermal System for the Treatment of Adults with Schizophrenia
• Secuado (asenapine) FDA Approval History

Amzeeq (minocycline) Topical Foam

Date of Approval: October 18, 2019
Company: Foamix Pharmaceuticals
Treatment for: Acne

Amzeeq (minocycline) is a topical foam formulation of the approved tetracycline drug minocycline indicated for the treatment of moderate to severe acne vulgaris in patients 9 years of age and older.

• FDA Approves Amzeeq (minocycline) Topical Foam for the Treatment of Moderate to Severe Acne
• Amzeeq (minocycline) FDA Approval History

Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) Tablets and Oral Granules

Date of Approval: October 21, 2019
Company: Vertex Pharmaceuticals Incorporated
Treatment for: Cystic Fibrosis

Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) is a triple combination regimen for the treatment of cystic fibrosis (CF) in patients ages 2 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation in the CFTR gene that is responsive to Trikafta based on in vitro data.

• FDA Approves Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) for Cystic Fibrosis Patients Ages 12 and Older Who Have at Least One F508del Mutation
• Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) FDA Approval History

Biorphen (phenylephrine hydrochloride) Injection

Date of Approval: October 21, 2019
Company: Eton Pharmaceuticals, Inc.
Treatment for: Hypotension

Biorphen (phenylephrine hydrochloride) injection is an alpha-1 adrenergic receptor agonist indicated for the treatment of hypotension during anesthesia.

• FDA Approves Biorphen (phenylephrine hydrochloride) Ready-to-Use Injection for Hypotension During Anesthesia
• Biorphen (phenylephrine hydrochloride) FDA Approval History

Vumerity (diroximel fumarate) Delayed-Release Capsules

Date of Approval: October 29, 2019
Company: Alkermes plc and Biogen
Treatment for: Multiple Sclerosis

Vumerity (diroximel fumarate) is a novel oral fumarate for the treatment of relapsing forms of multiple sclerosis (MS).

• FDA Approves Vumerity (diroximel fumarate) for Multiple Sclerosis
• Vumerity (diroximel fumarate) FDA Approval History

Talicia (amoxicillin, omeprazole and rifabutin) Delayed-Release Capsules

Date of Approval: November 4, 2019
Company: RedHill Biopharma Ltd.
Treatment for: Helicobacter Pylori Infection

Talicia (omeprazole magnesium, amoxicillin and rifabutin) is a fixed-dose combination of two antibiotics, (amoxicillin and rifabutin) and a proton pump inhibitor (omeprazole) for the treatment of Helicobacter pylori (H. pylori) infection.

• FDA Approves Talicia (omeprazole magnesium, amoxicillin and rifabutin) for the Treatment of H. pylori Infection in Adults
• Talicia (amoxicillin, omeprazole and rifabutin) FDA Approval History

Ziextenzo (pegfilgrastim-bmez) Injection

Date of Approval: November 4, 2019
Company: Sandoz, Inc.
Treatment for: Neutropenia Associated with Chemotherapy, Hematopoietic Syndrome of Acute Radiation Syndrome

Ziextenzo (pegfilgrastim-bmez) is a PEGylated growth colony-stimulating factor biosimilar to Neulasta (pegfilgrastim).

• FDA Approves Ziextenzo (pegfilgrastim-bmez), a Biosimilar to Neulasta
• Ziextenzo (pegfilgrastim-bmez) FDA Approval History

Reblozyl (luspatercept-aamt) for Injection

Date of Approval: November 8, 2019
Company: Bristol Myers Squibb
Treatment for: Anemia in Beta-Thalassemia; Anemia in Lower-Risk Myelodysplastic Syndromes

Reblozyl (luspatercept-aamt) is a first-in-class erythroid maturation agent (EMA) for use in the treatment of anemia in patients with beta thalassemia and anemia in patients with myelodysplastic syndromes.

• FDA Approves Reblozyl (luspatercept-aamt) for the Treatment of Anemia in Adults With Beta Thalassemia Who Require Regular Red Blood Cell Transfusions
• Reblozyl (luspatercept-aamt) FDA Approval History

Brukinsa (zanubrutinib) Capsules

Date of Approval: November 14, 2019
Company: BeiGene, Ltd.
Treatment for: Mantle Cell Lymphoma, Waldenström Macroglobulinemia, Chronic Lymphocytic Leukemia, Marginal Zone Lymphoma, Follicular Lymphoma

Brukinsa (zanubrutinib) is a Bruton’s tyrosine kinase (BTK) inhibitor used for the treatment of mantle cell lymphoma, Waldenström’s macroglobulinemia, marginal zone lymphoma, chronic lymphocytic leukemia or small lymphocytic lymphoma, and follicular lymphoma.

• FDA Approves Brukinsa (zanubrutinib) for the Treatment of Mantle Cell Lymphoma
• Brukinsa (zanubrutinib) FDA Approval History

Fetroja (cefiderocol) Injection

Date of Approval: November 14, 2019
Company: Shionogi & Co., Ltd.
Treatment for: Complicated Urinary Tract Infections; Hospital-acquired Bacterial Pneumonia; Ventilator-associated Bacterial Pneumonia

Fetroja (cefiderocol) is a siderophore cephalosporin indicated for the treatment of complicated urinary tract infections (cUTI), hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible Gram-negative microorganisms.

• FDA Approves Fetroja (cefiderocol) for the Treatment of Complicated Urinary Tract Infections
• Fetroja (cefiderocol) FDA Approval History

Adakveo (crizanlizumab-tmca) Injection

Date of Approval: November 15, 2019
Company: Novartis
Treatment for: Sickle Cell Disease, Sickle Cell Anemia

Adakveo (crizanlizumab-tmca) is a P-selectin inhibitor for the prevention of vaso-occlusive crises (VOCs) in patients with sickle cell disease (SCD).

• FDA Approves Adakveo (crizanlizumab-tmca) to Reduce Frequency of Pain Crises in Individuals Living with Sickle Cell Disease
• Adakveo (crizanlizumab-tmca) FDA Approval History

Abrilada (adalimumab-afzb) Injection

Date of Approval: November 15, 2019
Company: Pfizer Inc.
Treatment for: Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Crohn's Disease, Ulcerative Colitis, Plaque Psoriasis, Hidradenitis Suppurativa, Uveitis

Abrilada (adalimumab-afzb) is a tumor necrosis factor (TNF) blocker interchangeable 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 Abrilada (adalimumab-afzb), a Biosimilar to Humira
• Abrilada (adalimumab-afzb) FDA Approval History

Givlaari (givosiran) Injection

Date of Approval: November 20, 2019
Company: Alnylam Pharmaceuticals, Inc.
Treatment for: Acute Hepatic Porphyria

Givlaari (givosiran) is an aminolevulinate synthase 1-directed small interfering RNA (siRNA) indicated for the treatment of adults with acute hepatic porphyria (AHP).

• FDA Approves Givlaari (givosiran) for Acute Hepatic Porphyria
• Givlaari (givosiran) FDA Approval History

Xcopri (cenobamate) Tablets

Date of Approval: November 21, 2019
Company: SK Life Science, Inc.
Treatment for: Seizures

Xcopri (cenobamate) is an antiepileptic drug for the treatment of partial-onset seizures in adult patients.

• FDA Approves Xcopri (cenobamate) for the Treatment of Partial-Onset Seizures in Adults
• Xcopri (cenobamate) FDA Approval History

Exservan (riluzole) Oral Film

Date of Approval: November 22, 2019
Company: Aquestive Therapeutics, Inc.
Treatment for: Amyotrophic Lateral Sclerosis

Exservan (riluzole) an oral film formulation of the approved glutamate Inhibitor riluzole for the treatment of patients with amyotrophic lateral sclerosis (ALS) patients who have difficulty swallowing.

• FDA Approves Exservan (riluzole) Oral Film for the Treatment of Amyotrophic Lateral Sclerosis
• Exservan (riluzole) FDA Approval History

Oxbryta (voxelotor) Tablets

Date of Approval: November 25, 2019
Company: Pfizer Inc.
Treatment for: Sickle Cell Disease

Oxbryta (voxelotor) is an oral, HbS (sickle hemoglobin) polymerization inhibitor for the treatment of patients with sickle cell disease (SCD).

• FDA Approves Oxbryta (voxelotor) for the Treatment of Sickle Cell Disease
• Oxbryta (voxelotor) FDA Approval History

RediTrex (methotrexate) /pro/reditrex-injection.html

Date of Approval: November 27, 2019
Company: Cumberland Pharmaceuticals Inc.
Treatment for: Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriasis

RediTrex (methotrexate) is a folate analog metabolic inhibitor indicated for the management of rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (pJIA), and psoriasis.

• FDA Approves RediTrex (methotrexate) for Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, and Psoriasis
• RediTrex (methotrexate) FDA Approval History

Avsola (infliximab-axxq) Injection

Date of Approval: December 6, 2019
Company: Amgen Inc.
Treatment for: Crohn's Disease, Maintenance, Ulcerative Colitis, Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis, Plaque Psoriasis

Avsola (infliximab-axxq) is a tumor necrosis factor (TNF) blocker biosimilar to Remicade indicated for the treatment of Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.

• FDA Approves Avsola (infliximab-axxq), a Biosimilar to Remicade
• Avsola (infliximab-axxq) FDA Approval History

Vyondys 53 (golodirsen) Injection

Date of Approval: December 12, 2019
Company: Sarepta Therapeutics, Inc.
Treatment for: Duchenne Muscular Dystrophy

Vyondys 53 (golodirsen) is a phosphordiamidate morpholino oligimer for the treatment of Duchenne muscular dystrophy (DMD) in patients with a confirmed mutation amenable to exon 53 skipping.

• FDA Approves Vyondys 53 (golodirsen) Injection for the Treatment of Duchenne Muscular Dystrophy (DMD) in Patients Amenable to Skipping Exon 53
• Vyondys 53 (golodirsen) FDA Approval History

EluRyng (ethinyl estradiol and etonogestrel) Vaginal Ring

Date of Approval: December 11, 2019
Company: Amneal Pharmaceuticals, Inc.
Treatment for: Birth Control

EluRyng (ethinyl estradiol/etonogestrel vaginal ring) is an estrogen/progestin combination hormonal contraceptive (CHC) indicated for use by women to prevent pregnancy.

EluRyng is the first approved generic version of NuvaRing.

• FDA Approves EluRyng (etonogestrel/ethinyl estradiol vaginal ring), the First Generic NuvaRing
• EluRyng (ethinyl estradiol and etonogestrel) FDA Approval History

Nouress (cysteine hydrochloride) Injection

Date of Approval: December 13, 2019
Company: Avadel Pharmaceuticals plc
Treatment for: Total Parenteral Nutrition

Nouress (cysteine hydrochloride) is a sulfur-containing amino acid indicated for use as an additive to amino acid solutions to meet nutritional requirements of neonates requiring total parenteral nutrition.

• FDA Approves Nouress (cysteine hydrochloride) Injection for Treating Neonate Patients Requiring Total Parenteral Nutrition (TPN)
• Nouress (cysteine hydrochloride) FDA Approval History

Padcev (enfortumab vedotin-ejfv) Lyophilized Powder for Injection

Date of Approval: December 18, 2019
Company: Astellas Pharma US, Inc.
Treatment for: Urothelial Carcinoma

Padcev (enfortumab vedotin-ejfv) is a Nectin-4 directed antibody-drug conjugate (ADC) for the treatment of urothelial cancer.

• FDA Approves Padcev (enfortumab vedotin-ejfv) for Locally Advanced or Metastatic Urothelial Cancer, the Most Common Type of Bladder Cancer
• Padcev (enfortumab vedotin-ejfv) FDA Approval History

Arazlo (tazarotene) Lotion

Date of Approval: December 18, 2019
Company: Bausch Health Companies Inc.
Treatment for: Acne

Arazlo (tazarotene) is a lotion formulation of the approved retinoid tazarotene for the topical treatment of acne vulgaris in patients 9 years of age and older.

• FDA Approves Arazlo (tazarotene) Lotion for the Topical Treatment of Acne Vulgaris
• Arazlo (tazarotene) FDA Approval History

Ervebo (ebola zaire vaccine, live) Injection

Date of Approval: December 19, 2019
Company: Merck
Treatment for: Ebola Zaire Disease Prophylaxis

Ervebo (ebola zaire vaccine, live) is a vaccine indicated for the prevention of disease caused by Zaire ebolavirus in individuals 12 months of age and older.

• FDA Approves Ervebo (Ebola Zaire Vaccine, Live) for the Prevention of Disease Caused by Zaire Ebolavirus
• Ervebo (ebola zaire vaccine, live) FDA Approval History

Conjupri (levamlodipine maleate) Tablets

Date of Approval: December 19, 2019
Company: CSPC Pharmaceutical Group Limited
Treatment for: High Blood Pressure

Conjupri (levamlodipine maleate) is a calcium channel blocker indicated for the treatment of hypertension.

• FDA Approves Conjupri (levamlodipine maleate) for the Treatment of Hypertension
• Conjupri (levamlodipine maleate) FDA Approval History

Enhertu (fam-trastuzumab deruxtecan-nxki) Injection

Date of Approval: December 20, 2019
Company: AstraZeneca and Daiichi Sankyo Company, Limited
Treatment for: Breast Cancer, Gastric Cancer, Non Small Cell Lung Cancer, Solid Tumors

Enhertu (fam-trastuzumab deruxtecan-nxki) is a HER2-directed antibody and topoisomerase inhibitor conjugate used for the treatment of HER2-positive breast cancer, HER2-low or HER2-ultralow breast cancer, HER2-mutant non-small cell lung cancer, HER2-positive gastric or gastroesophageal junction adenocarcinoma, and HER2-positive solid tumors.

• FDA Approves Enhertu (fam-trastuzumab deruxtecan-nxki) for HER2-Positive Unresectable or Metastatic Breast Cancer Following Two or More Prior Anti-HER2 Based Regimens
• Enhertu (fam-trastuzumab deruxtecan-nxki) FDA Approval History

Ubrelvy (ubrogepant) Tablets

Date of Approval: December 23, 2019
Company: AbbVie Inc.
Treatment for: Migraine

Ubrelvy (ubrogepant) is a potent, orally-administered CGRP receptor antagonist for the acute treatment of migraine with or without aura in adults.

• FDA Approves Ubrelvy (ubrogepant) for the Acute Treatment of Migraine
• Ubrelvy (ubrogepant) FDA Approval History

Caplyta (lumateperone) Capsules

Date of Approval: December 20, 2019
Company: Intra-Cellular Therapies, Inc.
Treatment for: Schizophrenia, Bipolar Disorder

Caplyta (lumateperone) is an atypical antipsychotic for the treatment of schizophrenia and bipolar depression.

• FDA Approves Caplyta (lumateperone) for the Treatment of Schizophrenia in Adults
• Caplyta (lumateperone) FDA Approval History

Dayvigo (lemborexant) Tablets

Date of Approval: December 20, 2019
Company: Eisai Co., Ltd.
Treatment for: Insomnia

Dayvigo (lemborexant) is dual orexin receptor antagonist (DORA) for the treatment of insomnia.

• FDA Approves Dayvigo (lemborexant) for the Treatment of Insomnia in Adult Patients
• Dayvigo (lemborexant) FDA Approval History

Ortikos (budesonide) Extended-Release Capsules

Date of Approval: June 13, 2019
Company: Ferring Pharmaceuticals Inc.
Treatment for: Crohn's Disease, Active, Crohn's Disease, Maintenance

Ortikos (budesonide) is an oral corticosteroid indicated for the treatment of mild to moderate active Crohn’s disease.

• Ortikos (budesonide), the First and Only Once-Daily Dose for Treatment of Mild to Moderate Crohn’s Disease, Now Available in the U.S.
• Ortikos (budesonide) FDA Approval History

Polivy (polatuzumab vedotin-piiq) Injection

Date of Approval: June 10, 2019
Company: Genentech, Inc.
Treatment for: Diffuse Large B-Cell Lymphoma

Polivy (polatuzumab vedotin-piiq) is a CD79b-directed antibody and microtubule inhibitor conjugate used for the treatment of diffuse large B-cell lymphoma.

• FDA Approves Genentech's Polivy in Combination With R-CHP for People With Certain Types of Previously Untreated Diffuse Large B-Cell Lymphoma
• Polivy (polatuzumab vedotin-piiq) FDA Approval History