Granules gets ANDA approval for new drug
City-based pharmaceutical company Granules India Limited on Tuesday announced receiving ANDA approval for Amphetamine Mixed Salts ER capsules.
Hyderabad: City-based pharmaceutical company Granules India Limited on Tuesday announced receiving ANDA approval for Amphetamine Mixed Salts ER capsules.
The US Food and Drug Administration (US FDA) approved the Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals, Inc (GPI), a wholly-owned foreign subsidiary of the company, for Amphetamine Mixed Salts - 5mg, 10mg, 15mg, 20mg, 25mg, and 30mg Extended-Release (ER) capsules.
The pharma major said that the product is bioequivalent to the reference listed drug product (RLD), Adderall XR Extended-Release capsules of Takeda Pharmaceuticals USA Inc. This product will be manufactured at Granules manufacturing facility in Chantilly, Virginia and is expected to be launched shortly.
Priyanka Chigurupati, Executive Director, GPI said, "We are pleased to receive the approval of Amphetamine Mixed Salts ER Capsules within 10-months of ANDA filing, which is an Extended-Release dosage form of controlled substance (C-II)." Mixed Salts of a single-entity Amphetamine ER capsules are indicated for the treatment of ADHD.