New Delhi: Strides Shasun has received approval from the US health regulator to market Dutasteride capsules, used in treating enlarged prostate gland, in the American market.
The company has received approval from the US Food and Drug Administration (USFDA) to market Dutasteride capsules in the strength of 0.5 mg, Strides Shasun said in a regulatory filing.
According to IMS sales data, the US market for Dutasteride capsules is around USD 470 million.
“The product has gone off patent on November 20 and Strides Shasun is amongst the first wave of generic players to receive this approval,” the firm said.
The company will manufacture the product at its oral dosage facility at Bengaluru.