FDA approves 3 Aurobindo generics

SILVER SPRING, Md. — The Food and Drug Administration has approved three generics from Aurobindo Pharma this week — two prescription drugs and one OTC. On Tuesday, the agency approved Aurobindo’s generic Exforge (amlodipine and valsartan) tablets, and on Wednesday gave its OK to the company's generic Opana (oxymorphone HCl) and Pepcid AC (famotidine). 

 

Exforge is indicated to treat hypertension and high blood pressure, with an estimated market size of $123 million for the 12 months ending February 2016, according to IMS Health. Aurobindo’s generic will be available in 5- and 10-mg amlodipine/160-mg valsartan and 5- and 10-mg amlodipine/320-mg valsartan dosage strengths. The company expects to launch its generic in the first quarter of FY16.

 

The company’s Opana generic is indicated to treat moderate to severe acute pain where opioid use is appropriate and according to IMS Health, the product had a market size of $55.5 million for the 12 months ending February 2016. It will be available in 5- and 1—mg dosage strengths. 

 

Aurobindo’s generic of Pepcid AC will be available in 10- and 20-mg strength and be sold over the counter, with an expected launch in the second quarter of FY16. Its estimated market size, according to IMS Health, is about $31 million for the 12 months ended February 2016.