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New Drug Approvals

The following drugs have recently been approved by the FDA. Includes newly approved drugs and new indications for drugs already approved.

See also: Generic Approvals, Approval Process, New Indications and Dosage forms

Nayzilam (midazolam) Nasal Spray

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

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

Ruzurgi (amifampridine) Tablets

Company: Jacobus Pharmaceutical Company Inc.
Date of Approval: May 6, 2019
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.

Vyndaqel (tafamidis meglumine)

Company: Pfizer Inc.
Date of Approval: May 3, 2019
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.

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

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

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.

Dengvaxia (dengue tetravalent vaccine, live) Injection

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

Dengvaxia (dengue tetravalent vaccine, live) is a vaccine indicated for the prevention of dengue caused by dengue virus serotypes 1, 2, 3 and 4 in people 9 years through 16 years of age living in endemic areas who have laboratory-confirmed previous dengue infection.

Duobrii (halobetasol propionate and tazarotene) Lotion

Company: Bausch Health Companies Inc.
Date of Approval: April 25, 2019
Treatment for: Plaque Psoriasis

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

Eticovo (etanercept-ykro) Injection

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

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.

Skyrizi (risankizumab-rzaa) Injection

Company: AbbVie Inc.
Date of Approval: April 23, 2019
Treatment for: Plaque Psoriasis

Skyrizi (risankizumab-rzaa) is an interleukin-23 (IL-23) inhibitor for the treatment of plaque psoriasis.

Balversa (erdafitinib) Tablets

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

Balversa (erdafitinib) is a once-daily, oral, pan-fibroblast growth factor receptor for the treatment of patients with locally advanced or metastatic urothelial cancer.

Plenity (cellulose and citric acid) Capsules

Company: Gelesis
Date of Approval: April 12, 2019
Treatment for: Obesity

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.

Evenity (romosozumab-aqqg) Injection

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

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

Dovato (dolutegravir and lamivudine) Tablets

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

Dovato (dolutegravir and lamivudine) is a once-daily, single-tablet, two-drug regimen of the approved drugs dolutegravir (Tivicay) and lamivudine (Epivir) indicated for the treatment of HIV-1 infection in adults with no antiretroviral (ARV) treatment history and with no known resistance to either dolutegravir or lamivudine.

Asceniv (immune globulin intravenous, human – slra) Injection

Company: ADMA Biologics, Inc.
Date of Approval: April 1, 2019
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).

Mavenclad (cladribine) Tablets

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

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

Duaklir Pressair (aclidinium bromide and formoterol fumarate) Inhalation Powder

Company: Circassia Pharmaceuticals plc
Date of Approval: March 29, 2019
Treatment for: Chronic Obstructive Pulmonary Disease

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.

Avaclyr (acyclovir) Ophthalmic Ointment

Company: Fera Pharmaceuticals
Date of Approval: March 29, 2019
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.

Jatenzo (testosterone undecanoate) Capsules

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

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

Mayzent (siponimod) Tablets

Company: Novartis Pharmaceuticals Corporation
Date of Approval: March 26, 2019
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.

Sunosi (solriamfetol) Tablets

Company: Jazz Pharmaceuticals plc
Date of Approval: March 20, 2019
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).

Zulresso (brexanolone) Injection

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

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

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FDA Drug Approvals Archive

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