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Published on 4/3/2006 in the Prospect News Biotech Daily.

Aurobindo receives FDA approval for generic Ceftin

By Lisa Kerner

Erie, Pa., April 3 - Aurobindo Pharma Ltd. said it has received Food and Drug Administration approval for its Cefuroxime Axetil Tablets USP (125 mg, 250 mg, 500 mg), the generic version of Glaxo Wellcome's Ceftin.

Cefuroxime Axetil Tablets are indicated for the treatment of patients with strains of designated organisms in pharyngitis, tonsillitis, lower respiratory tract infections, urinary tract infections and skin structure infections, according to a news release.

The market for generic Cefuroxime Axetil is estimated at $50 million.

With this latest approval, Aurobindo said it has a total of 13 U.S. approvals, with an additional 10 tentative approvals.

Aurobindo, based in Hyderabad, India, manufactures generic pharmaceuticals and active pharmaceutical ingredients.


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