Zydus Lifesciences gets USFDA okay for Finasteride and Tadalafil Capsules

Ahmedabad: Zydus Lifesciences Limited has announced that the Company 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, as defined in section 505(j)(5)(B)(v)(III) of the FD&C Act and therefore is eligible for 180 days of CGT exclusivity," the Company stated.

Tadalafil is used to treat benign prostatic hyperplasia.

Benign prostatic hyperplasia is also known as prostate enlargement. In this disease, there is a noncancerous increase in size of the prostate gland. Symptoms may include Weak stream, frequent urination, trouble starting to urinate, inability to urinate, or loss of bladder control. 

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.

Read also: Zydus Lifesciences bags USFDA tentative nod for Edaravone Injection to treat amyotrophic lateral sclerosis

Medical Dialogues team had earlier reported that the Company had received final approval from the USFDA to market Silodosin Capsules, 4 mg and 8 mg (USRLD: Rapaflo capsules). Silodosin capsules are indicated to treat signs and symptoms of an enlarged prostate gland, which is also known as benign enlargement of the prostate (benign prostatic hyperplasia or BPH).

Read also: Zydus Lifesciences bags USFDA nod for Silodosin, Pregabalin capsules

Headquartered in Ahmedabad, Zydus Lifesciences Limited is an innovative, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group has a significant presence in cancer related therapies and offers a wide range of solutions with cytotoxic, supportive & targeted drugs. The group employs over 26,000 people worldwide, including 1,400 scientists engaged in R & D.