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10

Aurobindo gets USFDA nod for Cefotaxime injection

Posted on: November 10, 2009 at 2:57 pm | 109 views




Aurobindo Pharma | Antibiotic Cefotaxime Injection | US Food & Drug Administration

Aurobindo Pharma today said it has got the final approval from the US drug regulator to market its antibiotic Cefotaxime injection used for treating various infections.

The company has received final approvals from the US Food & Drug Administration (USFDA) for two abbreviated new drug applications (ANDAs)–Cefotaxime for Injection in the strength of 1g, 2g and Cefotaxime for Injection in 10g (pharmacy bulk pack) dose, Aurobindo Pharma said in a statement to the Bombay Stock Exchange (BSE).

Cefotaxime is the generic version of global drug major Sanofi Aventis’ Claforan injection.

The products are ready for launch, the Hyderabad-based drug maker said.

With these approvals, Aurobindo Pharma now has 109 ANDA approvals, which includes both tentative and final, from the USFDA.

-Business Standard.

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