Strides Arcolab receives US FDA approval for Levofloxacin Injection

Strides Arcolab Limited (Strides) today 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 diarrhea.

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. 

About Agila Specialties
Agila is the specialties unit of Strides Arcolab which was spun off as a separate division post the Company’s restructuring in 2009. It is focused on key domains such as oncolytics, penems, pencillins, cephalosporins, ophthalmics, peptides and biosimilars and operates from 7 world class global manufacturing facilities, including one of the largest steriles capacity in India and amongst the largest lyophilization (freeze drying) capacities in the world. Agila’s marketing network covers 70 countries and it has partnerships with some of the world’s leading pharmaceutical companies for both developed and emerging markets.

About Strides Arcolab Limited
Strides Arcolab, listed on the Bombay Stock Exchange Limited (532531) and National Stock Exchange of India Limited (STAR), is a global pharmaceutical company headquartered in Bangalore, India that develops and manufactures a wide range of IP-led niche pharmaceutical products with an emphasis on sterile injectables.

The company has 14 manufacturing facilities across 6 countries with presence in more than 75 countries in developed and emerging markets. Manufacturing is ably supported by a 350-scientist strong global R&D Centre located in Bangalore.

Additional information is available at the company’s website at www.stridesarco.com.