Strides Arcolab Ltd, a global pharmaceutical company which develops and manufactures a wide range of niche pharmaceutical products with an emphasis on sterile injectables, announced that it has received US Food and Drug Administration (FDA) approval for Polymyxin B for injection, USP, and 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 subconjuctivally in the treatment of infections of the eye caused by susceptible strains of Pseudomonas aeruginosa.
According to 2010 IMS data, the US market for injectable Polymyxin B approximated $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.