East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Vancomycin Hydrochloride for Oral Solution USP, 25 mg/mL and 50 mg/mL. Aurobindo Pharma’s Vancomycin Hydrochloride for Oral Solution USP,  are an AB-rated generic equivalent to the reference listed drug (RLD), Firvanq® for Oral Solution, manufactured by Azurity Pharmaceuticals, Inc.

Vancomycin Hydrochloride for Oral Solution are indicated for the:

• Treatment of Clostridium difficile-associated diarrhea in adults and pediatric patients less than 18 years of age.
• Treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) in adults and pediatric patients less than 18 years of age.