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Cystic Fibrosis

Forest Laboratories UK Ltd Submits Marketing Authorisation Application for the First Dry Powder Inhalation Antibiotic for Cystic Fibrosis Patients

Published in Lab Law Weekly, October 2nd, 2009

Forest Laboratories UK Ltd, (a wholly owned subsidiary of Forest Laboratories Inc) announced that following the successful completion of its pan-European multi-centre phase III study (the Freedom Study), it has applied to the European Medicines Evaluation Agency (EMEA) to licence its new formulation dry powder colistimethate sodium for inhalation (Colobreathe®) for use by Cystic Fibrosis patients. The new formulation which was wholly developed by Forest Laboratories UK has previously been granted orphan drug status by the European Medicines Evaluation Agency (EMEA) and when approved Colobreathe® will be made available throughout the EU in conjunction with its chosen partner...

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