Strides receives USFDA approval for headache drug

Strides Pharma Science announced that its step‐down wholly-owned subsidiary, Strides Pharma Global, Singapore, has received approval for Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules, 50 mg/325 mg/40 mg/30 mg from the United States Food & Drug Administration (USFDA).

The product is a generic version of Fioricet with Codeine Capsules, 50 mg/325 mg/40 mg/30 mg, of Teva Branded Pharmaceutical Product R&D. According to IQVIA MAT May 2020 data, the US market for Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules, 50 mg/325 mg/40 mg/30 mg is approximately $10 million.

The product will be marketed by Strides Pharma Inc. in the US market. The company has 124 cumulative ANDA filings with USFDA of which 87 ANDAs have been approved and 37 are pending approval.  Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules is indicated for the relief of the symptom complex of tension (or muscle contraction) headache.