FDA approves Orchid's oral suspension Cefprozil, generic of Bristol-Myers antibiotic Cefzil

By E. Janene Geiss

Philadelphia, Jan. 3 - Orchid Chemicals & Pharmaceuticals Ltd. announced Tuesday that the company has received formal approval from the Food and Drug Administration for its Abbreviated New Drug Application for Cefprozil for oral suspension USP, 125 mg/5 ml and 250 mg/5 ml.

Cefprozil is the generic version of Bristol-Myers Squibb's broad-spectrum cephalosporin antibiotic Cefzil, according to a company news release.

The current U.S. market size for Cefprozil oral suspension is $120 million, officials said.

The company said it is launching the product in the United States through its marketing alliance partner, Par Pharmaceuticals.

Orchid already has received the FDA approval for Cefprozil tablets USP, 250 mg and 500 mg, and is marketing it in the United States through a distribution alliance with Par.

The tablets and suspension formulas currently have combined brand sales of $237 million, officials said in the release.

Orchid is a Chennai, India, pharmaceutical company focused on bulk drugs, formulations and drug discovery.

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