Strides receives FDA nod for generic Neoral

Strides’ subsidiary, Strides Pharma Global in Singapore, has received approval from the Food and Drug Administration for cyclosporine softgel capsules (modified) in dosage strengths of 25 mg, 50 mg and 100 mg.

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

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Strides noted that it is the first Indian company to obtain approval for the product.

Strides immunosuppressant portfolio also includes mycophenolate mofetil tablets and capsules, tacrolimus capsules and cyclosporine softgel capsules.

Cyclosporine capsules have a market value of approximately $91 million, according to IQVIA.

[Read more: Strides Pharma obtains FDA clearance for generic Actigal]

The product will be manufactured at the company’s facility at Bengaluru and will be marketed by Strides Pharma in the United States.