Strides Arcolab Limited (Strides) announced that it has received US FDA approval for levofloxacin injection, 25 mg/mL packaged in 500mg/20 mL and 750mg/30 mL single-use vials.

Levofloxacin is a synthetic fluoroquinolone antibiotic used to treat mild to severe bacterial infections or bacterial infections that have failed to respond to other antibiotic classes. These include respiratory tract infections, cellulitis, urinary tract infections, prostatitis, anthrax, endocarditis, meningitis, pelvic inflammatory disease and traveller's diarrhoea.

According to IMS September 2010 data, the total market for levoflaxacin in the USA is approximated to be US$ 158 million of which US$ 5.68 million is for vials and the rest of the market is for bags. The product patent 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.

Levofloxacin is the second approval for Sagent Strides LLC in 2011. Strides is developing and supplying more than 25 injectable products for the USA market which will be marketed by Sagent.