Strides receives USFDA approval for Prednisone Tablets

Strides Pharma Science announced that its step-down wholly-owned subsidiary, Strides Pharma Global Pte, Singapore, has received approval for Prednisone Tablets USP, 2.5 mg and 5 mg from the United States Food & Drug Administration (USFDA). The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Deltasone Tablets, 2.5 mg and 5 mg, of Pharmacia and Upjohn Co.

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 September 2020 data, the US market for Prednisone Tablets USP, 2.5 mg and 5 mg is approximately $ 30 million. The product will be manufactured at the company’s flagship 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 93 ANDAs have been approved and 34 are pending approval.