Strides gets USFDA approval for butalbital, acetaminophen and caffeine tablets

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

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Butalbital, Acetaminophen, and Caffeine Tablets USP, 50 mg/325 mg/40 mg, of Actavis Laboratories FL.

Butalbital, acetaminophen, and caffeine tablets USP are indicated for the relief of the symptom complex of tension (or muscle contraction) headache.

According to IQVIA MAT July 2020 data, the US market for Butalbital, Acetaminophen, and Caffeine Tablets USP, 50 mg/325 mg/40 mg is approximately $40 million. The product will be marketed by Strides Pharma in the US market.

The company has 126 cumulative ANDA filings with USFDA of which 91 ANDAs have been approved and 35 are pending approval.