Strides Pharma Science Limited (Strides) announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte. Limited, 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).
According to IQVIA MAT December 2020 data, the US market for Prednisone Tablets USP, 10 mg and 20 mg is approximately US$ 60 Mn. The product will be manufactured at the company’s facility at Bengaluru and will be marketed by Strides Pharma Inc. in the US market.
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 treatment of different conditions such as allergic disorders, skin conditions, ulcerative colitis, arthritis, lupus, psoriasis, or breathing disorders.
The company has 127 cumulative ANDA filings with USFDA of which 98 ANDAs have been approved and 29 are pending approval.
