Lupin’s US arm gets tentative nod from US FDA for Generic Avelox Tablets

Pharma Major Lupin’s US subsidiary, Gavis Pharmaceuticals LLC., U.S.A. has received tentative approval for its Moxifloxacin Hydrochloride Tablets, 400 mg from the United States Food and Drug Administration (US FDA) to market a generic version of Bayer Healthcare Pharmaceuticals Inc.'s Avelox Tablets, 400 mg (base).

Lupin’s Moxifloxacin Hydrochloride Tablets, 400 mg are the AB rated generic equivalent of Bayer Healthcare Pharmaceuticals Inc.'s Aveloxe Tablets, 400 mg (base). It is a fluoroquinolone antibacterial indicated for treating infections in adults 18 years of age and older caused by designated susceptible bacteria in certain conditions. 

Lupin is a pharmaceutical company and is engaged in formulation of drugs and active pharmaceutical ingredients (APIs), generics, biotechnology, novel drug discovery and development, drug delivery systems and specialty pharmaceuticals.