Strides Pharma gets US FDA nod for generic anti-inflammatory drug

Drug firm Strides Pharma Science said it has received approval from the US health regulator for generic Prednisone tablets used as an anti-inflammatory medication

Drug firm Strides Pharma Science on Thursday said it has received approval from the US health regulator for generic Prednisone tablets used as an anti-inflammatory medication.

Strides Pharma Global Pte Ltd, Singapore, company's step-down wholly owned subsidiary, has received approval for Prednisone tablets USP in the strength of 1 mg from the United States Food & Drug Administration (USFDA), Strides Pharma Science said in a filing to the BSE.

The product is a generic version of Schering Corporation's Meticorten tablets in the same strength, it added.

The product will be manufactured at the company's facility at Bengaluru and will be marketed by Strides Pharma Inc in the US market,the filing said.

According to IQVIA MAT July 2020 data, the US market for Prednisone tablets USP 1 mg is approximately USD 12 million (about Rs 88 crore), it added.

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, Strides said.

The company has 126 cumulative abbreviated new drug application (ANDA) filings with USFDA of which 89 ANDAs have been approved and 37 are pending approval,it added.

Shares of Strides Pharma Science on Thursday closed 0.90 per cent lower at Rs606.50per scrip on the BSE.