Granules India gets USFDA approval for Butalbital, Acetaminophen, Caffeine capsules

Granules India Ltd on Thursday said its foreign subsidiary has received approval from the US health regulator for Butalbital, Acetaminophen and Caffeine Capsules used to treat tension headaches. In a regulatory filing the company said "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 Granules India Ltd for Butalbital, Acetaminophen and Caffeine Capsules USP, 50 mg/300 mg/40 mg." It is bioequivalent to the reference listed drug product, Butalbital, Acetaminophen and Caffeine Capsules USP, 50 mg/300 mg/40 mg, of Nexgen Pharma, Inc.

Butalbital, Acetaminophen and Caffeine Capsules are used to treat tension headaches. Butalbital, Acetaminophen and Caffeine Capsules USP, 50 mg/300 mg/40 mg had US sales of approximately 42 million dollar MAT for the most recent twelve months ending in February, 2020 according to IQVIA Health.

Granules now has a total of 25 ANDA approvals from USFDA..