Ranbaxy gets US FDA nod to market Cefprozil Suspension

Mumbai, July 1 (UNI) Ranbaxy Laboratories has received approval from the US Food and Drug Administration to manufacture and market Cefprozil for Oral Suspension USP, 125 mg/5ml and 250 mg/5ml.

Announcing this to BSE, the company said the Office of Generic Drugs, US Food and Drug Administration, has determined the company's formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Cefzil for Oral Suspension by Bristol Myers Squibb Company Pharmaceutical Research Institute. Total annual market sales for Cefprozil were 93 million dollar (IMS - MAT: March 2006).

Cefprozil Suspension is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated micro-organisms in the conditions listed: Pharyngitis/tonsillitis, Otitis Media, Acute Sinusitis, secondary bacterial infection of Acute Bronchitis and Acute Bacterial Exacerbation of Chronic Bronchitis and uncomplicated skin and skin-structure infections.

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