USFDA

Strides Pharma Science Limited (Strides) today announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Butalbital, Acetaminophen, and Caffeine Tablets USP, 50 mg/325 mg/40 mg from the United States Food & Drug Administration (USFDA).

Zydus Cadila has received final approval from the USFDA to market Cisatracurium Besylate Injection USP (US RLD: Nimbex ®) in the strength of 20 mg (base)/10 mL (2 mg/mL) Multiple-Dose Vial.

Alembic Pharmaceuticals Limited announced that the Company has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Vardenafil Hydrochloride Tablets, 2.5 mg (base), 5 mg (base), 10 mg (base), and 20 mg (base).

The U.S. Food and Drug Administration approved Fintepla (fenfluramine), a Schedule IV controlled substance, for the treatment of seizures associated with Dravet syndrome in patients age 2 and older. Dravet syndrome is a life-threatening, rare and chronic form of epilepsy. It is often characterized by severe and unrelenting seizures despite medical treatment.