Drug firm Strides Arcolab today said it has received the US health regulator's approval for the launch of Levofloxacin injections, an antibiotic, in the American market.
The company has received approval from the US Food and Drug Administration (USFDA) for Levofloxacin injections in strengths of 25 mg/mL, packaged in 500mg/20 mL and 750mg/30 mL single-use vials, Strides Arcolab said in a statement.
According to data from international drug research agency IMS for September, 2010, the total market for Levoflaxacin in the USA is nearly $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," the company said.
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, it said.
The infections that can be treated include respiratory tract infections, cellulitis, urinary tract infections, prostatitis, anthrax, endocarditis, meningitis, pelvic inflammatory disease and traveller's diarrhoea, it added.
Levofloxacin is the second approval received by Sagent Strides LLC, a joint venture between Strides Arcolab and Sagent Pharmaceuticals, in 2011. Strides is developing and supplying more than 25 injectable products for the USA market, which will be marketed by Sagent.
Shares of Strides Arcolab were being quoted at Rs 337 apiece on the Bombay Stock Exchange in late afternoon trade today, down 0.21% from their previous close.
