AMITYVILLE, N.Y. — The Food and Drug Administration has granted tentative approval to a generic antibiotic made by Hi-Tech Pharmacal, the drug maker said Friday.
Hi-Tech announced the tentative approval of levofloxacin oral solution in the 25 mg-per-mL strength. The drug is used to treat mild, moderate and severe bacterial infections in adults.
Levofloxacin oral solution is a generic version of Johnson & Johnson’s Levaquin. Levaquin had sales of $6 million in 2010, according to IMS Health. Levaquin expects to receive final approval in June, when Johnson & Johnson’s patent expires.