Granules receives USFDA approval for Amphetamine Mixed Salts ER capsules

Granules India announced today that the US Food & Drug Administration (US FDA) has 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. It 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.

Mixed Salts of a Single-Entity Amphetamine ER Capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

 

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