Zydus Lifesciences gets USFDA okay for Finasteride and Tadalafil Capsules
Tadalafil is used to treat benign prostatic hyperplasia.;
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.
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