Date: 10-Jul-2020

Strides Receives US FDA Approval For Generic Fioricet With Codeine Capsules

Strides Pharma Science has announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte. Singapore, has received approval for butalbital, acetaminophen, caffeine, and codeine phosphate capsules, from the United States Food & Drug Administration (FDA). These are in the strengths of 50 mg, 325 mg, 40 mg and 30 mg.

The product is a generic version of Fioricet with codeine capsules, 50 mg, 325 mg, 40 mg and 30 mg, of Teva Branded Pharmaceutical Product R&D, Inc.

According to IQVIA MAT May 2020 data, the US market for butalbital, acetaminophen, caffeine, and codeine phosphate capsules, of the above mentioned strengths is approximately US$ 10 million. These product will be marketed by Strides Pharma Inc. in the US market.

The company has 124 cumulative ANDA filings with US FDA of which 87 ANDAs have been approved and 37 are pending approval.

The butalbital, acetaminophen, caffeine, and codeine phosphate capsules is indicated for the relief of the symptom complex of tension or muscle contraction headaches.