Strides Pharma gets USFDA approval for generic product

Strides Pharma Science on Wednesday said it has received approval from the US health regulator to market a generic immunosuppressant medication in the American market. The Bengaluru-based firm said its step-down wholly-owned subsidiary, Strides Pharma Global, has received approval for Cyclosporine Softgel Capsules from the US Food & Drug Administration (USFDA). The product is therapeutically equivalent to Novartis' Neoral Capsules, it added.

Strides said it is the first Indian firm to get approval for the product. "The approval further strengthens Strides immunosuppressant portfolio for the US markets which now comprises of Mycophenolate Mofetil tablets and capsules, Tacrolimus capsules and Cyclosporine Softgel Capsules," it added. The medication is prescribed for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Cyclosporine is also used to treat severe rheumatoid arthritis and psoriasis. According to IQVIA MAT data, the US market for Cyclosporine Capsules USP, 25 mg, 50 mg, and 100 mg is around USD 91 million. Shares of the company were trading 3.7 per cent up at Rs 347.20 apiece on the BSE.