Strides Pharma gets USFDA nod to Butalbital, Acetaminophen, Caffeine tablets to treat headache
Bengaluru: Strides Pharma Science Limited has recently announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte. Limited, 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, Inc.
Butalbital, acetaminophen, and caffeine tablets USP is indicated for the relief of the symptom complex of tension (or muscle contraction) headache.
The product will be marketed by Strides Pharma Inc. 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.
The Company's global manufacturing sites are located in India‐ Bangalore (two locations), Pondicherry, and Chennai, Singapore, Italy‐ Milan, Kenya‐ Nairobi and United States‐Florida.