Zydus receives final approval from USFDA for Dutasteride Capsules

07 Oct 2017 Evaluate

Zydus Cadila has received the final approval from the US Food and Drug Administration (USFDA) to market Dutasteride Capsules, 0.5 mg. It will be manufactured at the group's formulations manufacturing facility at Moraiya, Ahmedabad. Dutasteride Capsules are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to improve symptoms, reduce the risk of acute urinary retention (AUR) and reduce the risk of the need for BPH-related surgery.

The group now has more than 160 approvals and has so far filed over 300 ANDAs since the commencement of the filing process in FY 2003-04.

Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies.

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