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Aurobindo Pharma Ltd Receives Final Anda Approval For Levofloxacin Injection


Friday, 25 Jan 2013 04:26am EST 

Aurobindo Pharma Ltd announced that it has received final approval from the US Food & Drug Administration (USFDA) 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 Inc.’s Levaquin Injection 25mg/mL and indicated for the treatment of adults with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms 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, India for manufacturing general liquid injectable and ophthalmic products and will be marketed and sold by Aurobindo's US subsidiary AuroMedics Pharma LLC. 

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723.65
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24 Jul 2014