USFDA

Eagle Pharmaceuticals, Inc., a specialty pharmaceutical company, announced that the US Food and Drug Administration (FDA) has approved Docetaxel injection, non-alcohol formula for the treatment of breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma, and head and neck cancer. Eagle entered into an exclusive licensing agreement with Teikoku Pharma USA Inc. in October 2015 to market, sell and distribute Docetaxel injection in the US.

Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Famotidine Tablets USP, 20 mg and 40 mg.

Sanofi Pasteur, the vaccines division of Sanofi, announced  that the Philippines have granted marketing approval to Dengvaxia®, making it the first vaccine to be licensed for the prevention of dengue in Asia.

U.S. Food and Drug Administration approved Uptravi (selexipag) tablets to treat adults with pulmonary arterial hypertension (PAH), a chronic, progressive, and debilitating rare lung disease that can lead to death or the need for transplantation. Uptravi is marketed by San Francisco-based Actelion Pharmaceuticals US, Inc.

The U.S. Food and Drug Administration approved Zurampic (lesinurad) to treat high levels of uric acid in the blood (hyperuricemia) associated with gout, when used in combination with a xanthine oxidase inhibitor (XOI), a type of drug approved to reduce the production of uric acid in the body. Zurampic is manufactured by AstraZeneca Pharmaceuticals LP, based in Wilmington, Delaware.

The US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for Boehringer Ingelheim's novel, 3rd-generation, epidermal growth factor receptor (EGFR) mutation-specific tyrosine kinase inhibitor (TKI), BI 1482694 (HM61713). The BTD is based on results from the phase I/II HM-EMSI-101 clinical trial which were presented at the ESMO Asia 2015 Congress in Singapore.

The US Food and Drug Administration approved Torax Medical In's Fenix continence restoration system to treat fecal incontinence in patients who are not candidates for, or have previously failed, medical or other surgical options.

The U.S. Food and Drug Administration approved a new indication for the LifeVest wearable cardioverter defibrillator. The LifeVest is approved for certain children who are at risk for sudden cardiac arrest, but are not candidates for an implantable defibrillator due to certain medical conditions or lack of parental consent. The LifeVest defibrillator is manufactured by the ZOLL Manufacturing Corporation based in Pittsburgh, Pennsylvania.

Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Methylprednisolone Sodium Succinate Injection USP, 40 mg/vial, 125 mg/vial, 500 mg/vial, and 2 g/vial.

The U.S. Food and Drug Administration approved Basaglar (insulin glargine injection), a long-acting human insulin analog to improve glycemic control in adult and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. Basaglar is manufactured by Eli Lilly and Company in Indianapolis, Indiana.