Drug firm Zydus Cadila today said it has received final approval from the US health regulator to market Dutasteride capsules, used for treatment of benign prostatic hyperplasia, in the American market.
The company has received the final approval from the United States Food and Drug Administration (USFDA) to market Dutasteride capsules in the strength of 0.5 mg, Zydus Cadila said in a BSE filing.
The product will be manufactured at the group's manufacturing facility at Moraiya in Ahmedabad, it added.
The capsules are indicated for treatment of benign prostatic hyperplasia (BPH) in men with enlarged prostrate to improve symptoms, reduce the risk of acute urinary retention and reduce the risk of the need for BPH-related surgery, Zydus Cadila said.
"The group now has more than 160 approvals and has so far filed over 300 abbreviated new drug applications (ANDAs)" since the commencement of the filing process by the company, it added.
Shares of Cadila Healthcare, the listed entity of the group, today closed at Rs 498.40 per scrip on BSE, down 0.47 per cent from its previous close.
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