Lupin gets tentative approval on Avelox generic

SILVER SPRING, Md. — The Food and Drug Administration has given Lupin’s U.S. arm, Gavia Pharmaceuticals, a tentative approval for its generic of Avelox (moxifloxacin HCl) tablets, the company announced Tuesday. 

 

The drug will be available from Lupin in 400-mg dosage strength, and the product had U.S. sales of $30.1 million for the 12 months ended June 2016, according to IMS Health data.