Strides Arcolab gets USFDA approval for Levofloxacin injection

21 Jun 2011 Evaluate

Strides Arcolab has received United States Food and Drug Administration (USFDA) approval for Levofloxacin injection, 25mg/ml packaged in 500mg/20ml and 750mg/30ml single-use vials. Levofloxacin is a synthetic fluoroquinolone antibiotic used to treat mild to serve bacterial infections or bacterial infections that have failed to respond to other antibiotic classes.

The total market for Levofloxacin in the USA is about $158 million of which $5.68 million is for vials and the rest of the market is for bags. The product patient expired on June 20, 2011 and this approval is amongst the first wave of approvals post patent expiry. The product is expected to be launched shortly.

Strides Arcolab is a global pharmaceuticals company headquartered in Banglore, India that develops and manufactures wide range of IP-led niche pharmaceuticals products with an emphasis on sterlite injectables.

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