Strides Shasun gets USFDA nod to market Dutasteride tablets

Our Bureau Bengaluru | Updated on January 22, 2018 Published on November 24, 2015

Strides Shasun has received an approval from the United States Food & Drug Administration (USFDA) for Dutasteride Capsules, 0.5 mg.   

Dutasteride capsules are used to treat men with an enlarged prostate, caused by the production of too much dihydrotestosterone, a sex hormone found in tee body. 

According to IMS data, the US market for Dutasteride Capsules is approximately $470 million and generic drug makers like Strides are seeing an opportunity in this area.  The product has gone off patent in November 20, 2015 and Strides Shasun is amongst the first wave of generic players to receive this approval, company executives said.

The product will be manufactured at the company’s Oral dosage facility at Bangalore and marketed by Strides Shasun in the US, the company said in a statement.

Published on November 24, 2015
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