Zydus Lifesciences Limited’s (formerly known as Cadila Healthcare Limited) has received final approval from the United States Food and Drug Administration (USFDA) to market Finasteride and Tadalafil Capsules USP 5 mg/5 mg. (USRLD: ENTADFI TM).

Zydus is the “first approved applicant” for Finasteride and Tadalafil Capsules, 5 mg/5 mg and is eligible for 180 days of CGT exclusivity. Finasteride and Tadalafil is used to treat benign prostatic hyperplasia.

The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ II, India.

The group now has 392 approvals and has so far filed over 460* ANDAs since the commencement of the filing process in FY 2003-04.