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European marketing approval for Forest’s Colobreathe dry powder inhaler

Forest Laboratories has received EMA approval to market Colobreathe dry powder colistimethate sodium inhalation powder for the treatment of P. aeruginosa infections in cystic fibrosis patients aged 6 years and older, according to the company. The company already markets a colistimethate sodium inhalation solution for nebulization under the brand name Colomycin in the UK and Ireland.

In February 2011, Forest reacquired European rights to Colobreathe from Gruenenthal. The company says that “The acquisition was a strategic fit for Forest as a first step to expand its commercial capabilities in Austria, Belgium, Germany, The Netherlands, Russia and Switzerland, in addition to its existing presence in the UK and Ireland.”

Forest Laboratories Europe CEO Raymond Stafford commented, “Colistimethate sodium has been available from Forest for many years in a standard nebulised presentation in the UK and Ireland. Instead of requiring up to thirty minutes of inhalation from a nebuliser Colobreathe is an advance to aid patient compliance and convenience utilizing the Turbospin inhaler which is small enough to be easily carried and is easy to administer the necessary dose in less than a minute. Colobreathe was fully developed in-house by Forest Europe, and its approval is a significant milestone as Forest expands our European footprint. Forest will be establishing affiliates in several additional European countries and some territories outside the EU to support the launch and commercialization of Colobreathe, as well as additional products in the Forest pipeline. We plan to introduce Colobreathe first in Germany by mid 2012 closely followed by other European countries and the UK in September.”

Read the Forest Laboratories press release.

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published on February 24, 2012

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