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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

Byfavo (remimazolam) Injection

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

Byfavo (remimazolam) is an ultra-short-acting intravenous benzodiazepine sedative/anesthetic for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less.

Rukobia (fostemsavir) Extended-Release Tablets

Company: ViiV Healthcare
Date of Approval: July 2, 2020
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.

Dojolvi (triheptanoin) Oral Liquid

Company: Ultragenyx Pharmaceutical Inc.
Date of Approval: June 30, 2020
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).

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

Company: Genentech, Inc.
Date of Approval: June 29, 2020
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.

Mycapssa (octreotide) Delayed-Release Capsules

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

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

Fintepla (fenfluramine) Oral Solution

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

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

Gimoti (metoclopramide) Nasal Spray

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

Zepzelca (lurbinectedin) Injection

Company: PharmaMar and Jazz Pharmaceuticals plc
Date of Approval: June 15, 2020
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.

Lyumjev (insulin lispro-aabc) Injection

Company: Eli Lilly and Company
Date of Approval: June 15, 2020
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.

Semglee (insulin glargine) Injection

Company: Mylan N.V. and Biocon Ltd.
Date of Approval: June 11, 2020
Treatment for: Diabetes Type 1, Diabetes Type 2

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

Uplizna (inebilizumab-cdon) Injection

Company: Viela Bio
Date of Approval: June 11, 2020
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.

Nyvepria (pegfilgrastim-apgf) Injection

Company: Pfizer Inc.
Date of Approval: June 10, 2020
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.

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

Company: AbbVie Inc.
Date of Approval: May 29, 2020
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.

Tauvid (flortaucipir F 18) Injection

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

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

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

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

artesunate for Injection

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

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

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

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

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.

Kynmobi (apomorphine hydrochloride) Sublingual Film

Company: Sunovion Pharmaceuticals Inc.
Date of Approval: May 21, 2020
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).

Cerianna (fluoroestradiol F18) Injection

Company: Zionexa USA
Date of Approval: May 20, 2020
Treatment for: Diagnostic

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.

Qinlock (ripretinib) Tablets

Company: Deciphera Pharmaceuticals, Inc.
Date of Approval: May 15, 2020
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.

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