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Skyepharma To File Flutiform In EU By End-March

British SkypePharma Plc. announced documentation filling process, will be concluded by the end of march, for European Medicines Agency approval of Flutiform drug (formoterol + fluticasone) indicated to treat asthma. The Food and Drug Administration delivered a complete response letter last September.
03-25-2010 |  17:24 hs.
Author: Victoria Auge |

British SkypePharma Plc. announced documentation filling process, to be concluded by the end of march, for European Medicines Agency approval of Flutiform drug (Formoterol + Fluticasone) indicated to treat asthma.

The drug is also being developed to treat chronic obstructive pulmonary disease (COPD). In Europe the drug maker has a marketing agreement with MundiPhama, that estimate launching the product during this year.

Last September 1st. 2009, the Food and Drug Administration delivered a complete response letter and requested additional clinical trials in order to grant approval. The additional information requested will delay its approval by the end of the second semester of 2011.

Due to this SkypePharma´s US partner, Abbott Laboratories Inc. decided to hand over control of the U.S. application to the company.

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