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Regulatory Bodies & Rulings
Aurobindo gets USFDA nod
Our Bureau
Hyderabad, April 3
Aurobindo Pharma Ltd has announced that it has received the United States Food and Drug Administration (USFDA) approval for Cefuroxime Axetil tablets 125 mg (base), 250 mg (base) and 500 mg (base). With this oral cephalosporin approval, the company's product basket for the US market has increased to 13 (final approvals), apart from 10 tentative approvals, the company said in a press release here on Monday. The size of the generics business of Cefuroxime Axetil 125/250/500 mg is estimated at around $50 million. These tablets are indicated for the treatment of patients with infections caused by susceptible strains of designated organisms in the diseases that include pharyngitis and tonsillitis, lower respiratory tract infections, urinary tract infections and skin structure infections. Cefuroxime Axetil Tablets USP, 125 mg (base), 250 mg (base) and 500 mg (base), is the generic version of Glaxo Wellcome's Ceftin, the release said.
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