Strides gets USFDA approval for Prednisone Tablets

Strides Pharma Science announced that its step-down wholly-owned subsidiary, Strides Pharma Global, Singapore, has received approval for Prednisone Tablets USP, 10 mg and 20 mg from the United States Food & Drug Administration (USFDA). The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Deltasone Tablets, 10 mg and 20 mg, of Pharmacia and Upjohn Co. (Pharmacia).

Prednisone belongs to a class of drugs known as corticosteroids and is used as an anti-inflammatory or an immunosuppressant medication. It is used in the treatment of different conditions such as allergic disorders, skin conditions, ulcerative colitis, arthritis, lupus, psoriasis, or breathing disorders.

According to IQVIA MAT December 2020 data, the US market for Prednisone Tablets USP, 10 mg and 20 mg is approximately $60 million. The product will be manufactured at the company’s facility at Bengaluru and will be marketed by Strides Pharma in the US market.

The company has 127 cumulative ANDA filings with USFDA of which 98 ANDAs have been approved and 29 are pending approval.