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New Drug Approvals Archive - June 2020

See also: New Indications and Dosage Forms for June 2020

June 2020

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

Fintepla (fenfluramine) is an amphetamine derivative indicated for the treatment of seizures associated with Dravet 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).

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