Lupin receives FDA approval for generic antibiotic cefprozil

By Angela McDaniels

Seattle, Dec. 9 - Lupin Ltd. said the Food and Drug Administration has approved its Abbreviated New Drug Application for cefprozil tablets USP, 250 mg and 500 mg.

Cefprozil is the generic equivalent of Bristol-Myers Squibb's antibiotic Cefzil.

"We are delighted with the approval of cefprozil tablets and look forward to launching the product post-patent expiry on Dec. 23 and gaining a profitable market share," chairman D.B. Gupta said in a company news release.

This is the company's ninth Abbreviated New Drug Application approved by the FDA to date and the fourth in fiscal 2005.

Lupin is based in Mumbai, India, where it manufactures active pharmaceutical ingredients and finished products.

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