New Delhi: Drug firm Zydus Cadila said it has received tentative approval from the US health regulator to market Vardenafil Hydrochloride tablets used for the treatment of erectile dysfunction in the American market.
The company said in a statement that it has received nod from the United States Food and Drug Administration (USFDA) to market the tablets in the strengths of 2.5 mg, 5 mg, 10 mg and 20 mg.
The product will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad, it added.
“The drug is an erectile dysfunction agent that works by blocking a certain enzyme (phosphodiesterase-PDE5) used to treat erectile dysfunction,” Zydus Cadila said.
The group currently has 212 approvals and has so far filed over 330 abbreviated new drug applications (ANDAs) since the commencement of the filing process by the company, it added.