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Lupin receives US FDA approval for cefprozil tabs
Our Bureau, Mumbai | Friday, December 9, 2005, 08:00 Hrs  [IST]

Lupin Ltd has received US FDA approval for its abbreviated new drug application (ANDA) for cefprozil tablets USP, 250 mg and 500 mg, according to a company release.

Cefprozil is the generic equivalent of Bristol Myers Squibb's Cefzil. The tablet market in the US is USD 117 million as per IMS MAT June 2005 data.

Dr. D B Gupta, chairman, Lupin said, "We are delighted with the approval of cefprozil tablets and look forward to launching the product post patent expiry on December 23, 2005, and gaining a profitable market share. The expeditious review and approval by the US FDA is a sign of their confidence in Lupin and the quality of our filings.”

This is the company's ninth ANDA approval by the US FDA till date and the fourth in this financial year.

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