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.
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