Lupin receives US FDA tentative approval for antibacterial drug moxifloxacin

Lupin Limited has received tentative approval for moxifloxacin hydrochloride tablet, an antibacterial drug, from the US Food and Drug Administration (FDA).

The company’s US subsidiary, Gavis Pharmaceuticals LLC, USA has received tentative approval for its moxifloxacin hydrochloride tablet, 400 mg from the US FDA to market a generic version of Bayer Healthcare Pharmaceuticals Inc’s Avelox tablet, 400 mg (base),” said Lupin in a press release.

Lupin’s moxifloxacin hydrochloride tablet is a fluoroquinolone antibacterial indicated for treating infections in adults 18 years of age and older caused by designated susceptible bacteria in certain conditions.

Avelox had US sales of $ 30.1 million, according to IMS MAT June 2016.