Zydus Cadila has received the tentative approval from the US Food and Drug Administration (USFDA) to market Vardenafil Hydrochloride Tablets (US RLD-Levitra) in the strengths of 2.5 mg, 5 mg, 10 mg and 20 mg.
The drug is an erectile dysfunction agent that works by blocking a certain enzyme (phosphodiesterase-PDE5) used to treat erectile dysfunction (impotence). It will be manufactured at the group’s formulations manufacturing facility at SEZ. In line with this, the group now has 212 approvals and has so far filed over 330 ANDAs since the commencement of the filing process in FY 2003-04.
Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies.