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Ranbaxy received full market approval from the US Food and Drug Admnistration for its anti-infective agent ?Clarithromycin? oral suspension.
Haryana, India (Oct. 2)-Ranbaxy received full market approval from the US Food and Drug Admnistration for its anti-infective agent “Clarithromycin” oral suspension, USP (125 mg/5 mL and 250 mg/5 mL). The approval makes the company the first to win generic approval for the oral suspension form and the tablet form.
FDA’s Office of Generic Drugs determined the Ranbaxy’s formulation was bioequivalent and offers the same therapeutic effect as that of the reference listed drug “Biaxin” granules of Abbott Laboratories.
Total annual market sales for Clarithromycin were $99.7 million, with suspension sales totaling $25.3 million.