Final US OK for Ranbaxy's cefprozil
Ranbaxy Pharmaceuticals Inc, a wholly-owned subsidiary of India's Ranbaxy Laboratories, has received approval from the US Food and Drug Administration to manufacture and market cefprozil tablets USP, 250mg and 500mg.
The FDA's Office of Generic Drugs has determined the Ranbaxy formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Cefzil from originator Bristol-Myers Squibb. Total annual market sales for cefprozil tablets were $76.6 million (IMS - moving annual total to September 2006).
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