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
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, and cervical 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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