USFDA grants approval for generic Cyclosporine Soft Gel capsules

Cyclosporine is used as an immunosuppressant medication.

Picture: Pixabay

Last Updated on August 5, 2022 by The Health Master

The United States Food & Drug Administration (USFDA) has approved cyclosporine soft gel capsules USP (Modified), 25 mg, 50 mg, and 100 mg, according to a statement released by Strides Pharma Science Limited (Strides), a step-down wholly owned subsidiary.

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Neoral capsules 25 mg, 50 mg, and 100 mg, of Novartis Pharmaceuticals Corporation.

Cyclosporine soft gel capsules are part of Strides’ niche product portfolio with limited competition in the US market. Strides is the first Indian company to get approval for the product.

The approval further strengthens Strides immunosuppressant portfolio for the US markets which now comprises mycophenolate mofetil tablets and capsules, tacrolimus capsules, and cyclosporine soft gel capsules.

According to IQVIA MAT data, the US market for cyclosporine capsules USP, 25 mg, 50 mg, and 100 mg is approximately US$ 91 million.

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

The company has 279 cumulative ANDA filings (including the recently acquired portfolio from Endo at Chestnut Ridge) with the USFDA, of which 259 ANDAs have been approved and 20 are pending approval. The company has set a target to launch 20 new products every year in the US.

Cyclosporine is used as an immunosuppressant medication. It is prescribed for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. The drug is also used to treat severe rheumatoid arthritis and psoriasis.

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