Granules India announced 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 Granules India for Butalbital, Acetaminophen and Caffeine Capsules USP, 50 mg/300 mg/40 mg. It is bioequivalent to the reference listed drug product (RLD), Butalbital, Acetaminophen and Caffeine Capsules USP, 50 mg/300 mg/40 mg, of Nexgen Pharma, Inc.
Butalbital, Acetaminophen and Caffeine Capsules are used for the relief of the symptom complex of tension (or muscle contraction) headache.
Butalbital, Acetaminophen and Caffeine Capsules USP, 50 mg/300 mg/40 mg had U.S. sales of approximately $42 million 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 US FDA (23 Final approvals and 2 tentative approvals).
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