Zydus Cadila has launched Vardenafil Hydrochloride Tablets (US RLD – LEVITRA Tablets), 2.5 mg, 5 mg, 10 mg and 20 mg in the US market upon receiving the final approval from the USFDA.
Manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad, the medication is indicated for the treatment of erectile dysfunction, the company said in a filing.
The group also received the final approval from the USFDA to market Ursodiol Tablets, 250 mg (US RLD — URSO 250 tablets) and 500 mg (US RLD — URSO Forte tablets). It will be manufactured at the group’s formulations manufacturing facility at Baddi. It is indicated for the treatment of patients with primary biliary cirrhosis, a chronic disease in which the bile ducts in the liver are slowly destroyed.
The group now has 226 approvals and has so far filed over 330 ANDAS since the commencement of the filing process in FY 2003-04, the company added.