Aurobindo Pharma gets USFDA nod for Cefotaxime Injection
Aurobindo Pharma, one of the largest API manufacturers in Asia, has secured final nod from US Food and Drug administration (USFDA) for two ANDAs namely Cefotaxime for injection USP in the strength of 500 mg, 1g, 2g and Cefotaxime for injection USP 10g in pharmacy bulk pack.
Cefotaxime for Injection USP is the generic equivalent to Claforan for injection of Sanofi Aventis US. The drug is indicated in Lower respiratory tract infections, Genitourinary infections, Gynecologic infections, Intra-abdominal infections, Bone and/or joint infections, Central nervous system infections, Bacteremia/Septicemia Skin and skin structure infections.
With latest approval, Aurobindo now has a total of 109 ANDA approvals (80 final approvals and 29 tentative approvals) from USFDA.