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08 Apr 2011
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Hi-Tech Pharmacal levofloxacin oral solution wins FDA tentative approval

By PBR Staff Writer
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Hi-Tech Pharmacal has received the US Food and Drug Administration's (FDA) tentative approval for its abbreviated new drug application (ANDA) of levofloxacin oral solution 25mg/ml.

The product is indicated for the treatment of adults with mild, moderate and severe infections.

Levofloxacin oral solution 25mg/ml is the generic version of McNeil Pharmaceutical’s Levaquin oral solution, is used to treat mild, moderate and severe infections in adults.

Hi-Tech Pharmacal expects to receive final approval from the FDA in June 2011 when the brand’s pediatric exclusivity expires related to patent number 5,053,407.

Hi-Tech intends to introduce of levofloxacin oral solution 25mg/ml in June 2011 upon receipt of final approval.