New Delhi: 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.