India-based generics firm Ranbaxy has received approval from the FDA to manufacture and market a copycat version of Bristol-Myers Squibb's antibiotic, Cefzil.
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The approval covers cefprozil for oral suspension in 125mg/5mL and 250mg/5mL dosages. Cefprozil suspension is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in conditions including pharyngitis/tonsillitis, acute sinusitis, and uncomplicated skin and skin-structure infections.
“Ranbaxy is pleased to market this product as an addition to our ever growing product portfolio of anti-infectives,” said Jim Meehan, vice president of sales and marketing for Ranbaxy Pharmaceuticals, a wholly owned subsidiary of Ranbaxy Laboratories Limited. “Our plans are to bring this product to the market immediately.”
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