Aurobindo gets FDA nod for cefuroxime axetil

New Delhi, Apr 3 (UNI) Hyderabad-based Aurobindo Pharma Ltd today said it has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application for anti-bacterial cefuroxime axetil tablets.

Cefuroxime Axetil tablets are indicated for the treatment of patients with infections caused by susceptible strains of designated organisms in the following diseases: Pharyngitis and Tonsillitis, Lower Respiratory Tract Infections, Urinary Tract Infections and Skin Structure Infections.

The size of generics business of Cefuroxime Axetil 125/250/500 mg is estimated at around 50 million dollars.

With this Oral Cephalosporin approval, the Company's product basket for the US market has increased to 13 (Final approvals).

Apart from this, the Company has 10 Tentative Approvals for the US market.

Cefuroxime Axetil Tablets USP, 125 mg (base), 250 mg (base), 500 mg (base) is the generic version of Glaxo Wellcomes Ceftin.

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