Forest Laboratories receives EMA approval for Colobreathe

Pharmaceutical Company Product News

Forest Laboratories has been granted European regulatory approval for its new Colobreathe dry powder inhaler.

The European Medicines Agency (EMA) has ratified the dry powder colistimethate sodium inhaler for treating cystic fibrosis patients aged six years and older with chronic lung infections caused by P. aeruginosa.

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Colobreathe has demonstrated its advantages compared to a leading competitor in a clinical trial, during which it was proven to offer better patient acceptability.

It will be introduced in Germany first in mid-2012, with a launch in the UK and other European nations to follow in September.

Raymond Stafford, chief executive officer of Forest Laboratories Europe, said: "Forest will be establishing affiliates in several additional European countries and some territories outside the EU to support the launch and commercialisation of Colobreathe, as well as additional products in the Forest pipeline."

Earlier this month, the company published new clinical data showing the efficacy of cariprazine, a treatment for acute mania associated with bipolar I disorder developed in partnership with Gedeon Richter.

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