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