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Corporate - Regulatory Bodies & Rulings
US nod for Aurobindo drugs

Hyderabad, Nov. 9

Aurobindo Pharma Ltd has received final approval from the US Food and Drug Administration for two abbreviated new drug applications (ANDAs) – Cefotaxime for injection (in 500 mg, 1g and 2g) and cefotaxime injection in 10g pharmacy bulk pack, the Hyderabad-based company informed BSE. Cefotaxime for injection is the generic equivalent to Claforan for injection of Sanofi Aventis US. It falls under the anti-betallactum segment. The product was ready for launch, it said. —

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