Par gets FDA approval for Cefprozil, generic of Bristol-Myers antibiotic

By E. Janene Geiss

Philadelphia, Dec. 23 - Par Pharmaceutical Cos., Inc. announced Friday that it has received final approval from the Food and Drug Administration for its Abbreviated New Drug Application for Cefprozil tablets.

Cefprozil is the generic version of Bristol-Myers Squibb Co.'s broad-spectrum cephalosporin antibiotic Cefzil.

Annual U.S. sales of Cefzil tablets exceed $100 million, according to IMS Health, officials said in a news release.

Par said it will begin shipping the product immediately. Cefprozil tablets will be available in 250 mg and 500 mg strengths.

Par, based in Spring Valley, N.Y., develops, manufactures and markets generic drugs and innovative branded pharmaceuticals for specialty markets.

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