Aurobindo Pharma has received final approval from the US Food & Drug Administration (US FDA) to manufacture and market Levofloxacin injection, 25mg/mL, packaged in 500mg/20mL and 750mg/30mL single-use vials (ANDA 202328).
Levofloxacin Injection, 25mg/mL packaged in 500mg/20mL and 750mg/30mL single-use vials is the generic equivalent of Janssen Pharmaceuticals levaquin injection 25mg/mL and indicated for the treatment of adults with mild, moderate, and severe infections caused by susceptible isolates of the designated micro organisms such as pneumonia. Acute Bacterial sinusitis or complicated urinary tract infections etc and intravenous administration offers a route of administration advantageous to the patient.
These ANDAs have been approved out of Unit IV formulation facility in Hyderabad for manufacturing general liquid injectable and ophthalmic products and will be marketed and sold by Aurobindo’s US subsidiary AuroMedics Pharma.
Aurobindo now has a total of 175 ANDA approvals (150 final approvals including two from Aurolife Pharma and 25 tentative approvals) from US FDA.
EP News Bureau – Mumbai