Zydus receives USFDA's final nod for Finasteride, Tadalafil capsules; qualifies for CGT exclusivity

With the latest approval, Zydus now has a total of 392 approvals and has submitted over 460 Abbreviated New Drug Applications (ANDAs) since the initiation of the filing process in financial year 2003-04.

Zydus Lifesciences Limited has obtained final approval from the United States Food and Drug Administration (USFDA) to market its Finasteride and Tadalafil Capsules USP 5 mg/5 mg (USRLD: ENTADFI TM), the company announced in an exchange filing on March 16.

Notably, Zydus is the "first approved applicant" for Finasteride and Tadalafil Capsules, 5 mg/5 mg, as per section 505(j)(5)(B)(v)(III) of the FD&C Act, qualifying for 180 days of Competitive Generic Therapy (CGT) exclusivity, it mentioned in the filing.

This medication is used in the treatment of benign prostatic hyperplasia and will be produced at the company’s formulation manufacturing facility in Gujarat's Ahmedabad SEZ II, Zydus noted in its statement.

With the latest approval, Zydus now has a total of 392 approvals and has submitted over 460 Abbreviated New Drug Applications (ANDAs) since the initiation of the filing process in financial year 2003-04.