US FDA approves Strides Arcolab's levofloxacin injection

Bangalore: Strides Arcolab Limited (Strides) today said 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 is a synthetic chemotherapeutic antibiotic of the fluoroquinolone drug class 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 diarrhea.

According to IMS September 2010 data, the total market for Levoflaxacin in the USA  is approximated to be $158 million of which $ 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.

It is sold under various brand names, such as Levaquin and Tavanic, the most common. Oral and I.V. Levaquin are not licensed by the FDA for use in children due to the risk of reversible or irreversible damage.

Levofloxacin is the second approval for Sagent Strides LLC in 2011, the joint venture between Strides and privately-held specialty pharmaceutical company 
Sagent Pharmaceuticals, Inc..

 The two companies haqve agreed to jointly develop, supply and  market injectable products for the US market developed by Strides and marketed in the US by Sagent.

Strides says it is developing and supplying more than 25 injectable products for the USA market, which will be marketed by Sagent.