Strides Pharma Science Limited (Strides) on Thursday announced that its step-down wholly -owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Prednisone Tablets USP, 1 mg from the United States Food & Drug Administration (USFDA).
The product is a generic version of Meticorten Tablets, 1 mg of Schering Corporation. 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 July 2020 data, the US market for Prednisone Tablets USP, 1 mg is approximately $12 million. The product will be manufactured at the company’s flagship facility at Bengaluru and will be marketed by Strides Pharma Inc in the US market.
The company has 126 cumulative ANDA filings with USFDA of which 89 ANDAs have been approved, and 37 are pending approval.