Strides gets FDA approval to sell generic Dutasteride in US

Market size for Dutasteride capsules is $470 mn

Pharma major Strides Shasun Ltd said it has US food and drug administration (FDA) approval to sell generic capsules of Dutasteride, a drug used to treat prostrate gland enlargement.

Strides says it is the first generic drugs player to get approval to sell the drug in the US, which went off patent on November 20, the firm said in a statement.

According to IMS data, the US market for Dutasteride Capsules is approximately $ 470 million. Strides Shasun is amongst the first wave of generic players to receive this approval.

The product will be manufactured at the company's oral dosage facility in Bengaluru and marketed by Strides Shasun in the US market.