Aurobindo Pharma's generic Diovan approved

HYDERABAD, India — Aurobindo Pharma on Tuesday announced that the company has received final approval from the U.S. Food & Drug Administration to manufacture and market Valsartan Tablets USP, 40mg, 80mg, 160mg and 320mg (ANDA 202223). 

 

Valsartan Tablets are the generic equivalent to Novartis' Diovan Tablets, which is indicated for the treatment of hypertension to lower blood pressure. The product has a market size of approximately $2 billion for the 12 months ending October 2014, according to IMS.

 

The product is ready for launch.

 

Aurobindo now has a total of 195 ANDA approvals (170 final approvals, including seven from Aurolife Pharma and 25 tentative approvals from the FDA).