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New Drug Approvals Archive - June 2019

See also: New Indications and Dosage Forms for June 2019

June 2019

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–drug conjugate indicated in combination with bendamustine and rituximab for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma, who have received at least two prior therapies.

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.

Vyleesi (bremelanotide) Injection

Date of Approval: June 21, 2019
Company: AMAG 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.

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:

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.

Myxredlin (insulin human in sodium chloride) Injection

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

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.

Ortikos (budesonide) Extended-Release Capsules

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

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

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