Drug firm Strides Pharma Science on Tuesday said its subsidiary, Strides Pharma Global Pte Ltd, has received approval from the US health regulator for Butalbital, Acetaminophen, and Caffeine tablets, used to treat tension headache. The approved product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Butalbital, Acetaminophen, and Caffeine tablets of Actavis Laboratories FL Inc.
Strides Pharma Global Pte Ltd, Singapore, has received approval for Butalbital, Acetaminophen, and Caffeine tablets USP in the strengths of 50 mg/325 mg/40 mg from the United States Food and Drug Administration (USFDA),Strides Pharma Science said in a regulatory filing. Quoting IQVIA MAT July 2020 data, Strides Pharma Science said the US market for Butalbital, Acetaminophen, and Caffeine tablets is approximately USD 40 million.
”The product will be marketed by Strides Pharma Inc in the US market,” the company added. The company has 126 cumulative abbreviated new drug application (ANDA) filings with USFDA of which 91 ANDAs have been approved and 35 are pending for approval.
