Granules India on Thursday said the U.S. Food and Drug Administration (USFDA) has approved the Abbreviated New Drug Application (ANDA) filed by the company’s wholly owned subsidiary Granules Pharmaceuticals Inc. for Butalbital, Acetaminophen and Caffeine capsules USP, 50 mg/300 mg/40 mg. The product is the bioequivalent to the reference-listed drug product (RLD), Butalbital, Acetaminophen and Caffeine capsules USP, 50 mg/300 mg/40 mg of Nexgen Pharma Inc. It is used for the relief of the symptom complex of tension (or muscle contraction) headache.
The approved product had U.S. sales of about $42 million MAT for the most recent 12 months ended in February 2020, a Granules release said citing IQVIA Health numbers.
