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

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.