Zydus Cadila has received final approval from the US health regulator to market Dutasteride and Tamsulosin Hydrochloride capsules.
The drug is used to treat symptoms of Benign Prostatic Hyperplasia (BPH) — also called prostate gland enlargement.
The approval has been granted in the strengths of 0.5mg/0.4 mg, the company said in a BSE filing.
Zydus Cadila said the drug will be produced at the group`s formulations manufacturing facility at Moraiya, Ahmedabad.
The group has more than 190 approvals and so far filed over 320 abbreviated new drug applications (ANDAs) since it started filings in 2003-04.
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