Express Pharma

Lupin receives tentative approval for generic Avelox tablets

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It is a fluoroquinolone antibacterial indicated for treating infections in adults

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

Lupin’s Moxifloxacin Hydrochloride tablets, 400 mg are the AB rated generic equivalent of Bayer Healthcare Pharmaceuticals Inc.’s Avelox 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.

Avelox had US sales of $30.1 million (IMS MAT June 2016).

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