Strides Arcolab Limited (Strides) today announced that it has received US FDA approval for Polymyxin B for injection, USP, an antibacterial drug, in 500,000 units per vial, latex-free glass vials
Polymyxin B sulfate is an antibacterial drug used in the treatment of infections of the urinary tract, meninges and bloodstream caused by susceptible strains of Pseudomonas aeruginosa. It may also be used topically and subconjunctivally in the treatment of infections of the eye caused by susceptible strains of Pseudomonas aeruginosa.
According to 2010 IMS data, the U.S. market for Injectable Polymyxin B approximated USD 8 Million, with few approved players. As with all products in the Strides- Sagent JV, Polymyxin B features the Prevent IV Measures packaging and labelling designed to aid in the reduction of medication errors.
The product is expected to be launched in Q3 2011
Polymyxin is the third product approval for Sagent Strides LLC in 2011 and the eleventh approval under the Sagent-Strides partnership. Strides is developing and supplying more than 25 injectable products for the USA market which will be marketed by Sagent.