Meda announces PDUFA timeline for Dymista

 | Source: Meda AB Meda AB 

Meda announces PDUFA timeline for Dymista

 

FDA, the U.S. Food and Drug Administration, has informed Meda that the PDUFA
(Prescription Drug User Fee Act) date for Dymista will be early May 2012.

FDA needs an additional three months to review earlier submitted data, related
to CMC (Chemistry, Manufacturing and Controls). The extension of the timeline is
in line with FDA’s standard review regulations.

For further inquiries, please contact:

Anders Larnholt, Vice President Corporate Development & IR ph: 46 709-458 878

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