Zydus receives final nod for Dutasteride Capsules from USFDA
DSIJ Intelligence / 07 Oct 2017
Cadila Healthcare informed on Friday that the company’s wholly owned subsidiary Zydus Cadila received the final approval from the US Food and Drug Association to market Dutasteride Capsules
Cadila Healthcare informed on Friday that the company’s wholly owned subsidiary Zydus Cadila received the final approval from the US Food and Drug Association to market Dutasteride Capsules, 0.5 mg. The drug will be manufactured at the company’s formulations manufacturing facility at Moraiya, Ahmedabad.
The drug is indicated for the treatment of sympotomatic benign prostatic hyperplasis (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.
On Friday, Cadila Healthcare closed lower by 0.04 per cent at Rs 500 per share on BSE. While the stock had touched an intraday high and an intraday low of Rs 504 per share and Rs 495.05 per share on BSE, respectively.
Cadila Healthcare had hit its 52-week high of Rs 558 per share on June 12, 2017 and its 52 week low of Rs 329.60 per share on December 26, 2016 on BSE, respectively.
At present, the company has more than 160 approvals and has so far filed over 300 ANDAs since the commencement of the filing process in FY04.
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