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Article: InterMune Announces Appointments of Senior Leadership to Prepare for Potential Launch of Pirfenidone.
- Article from:
- PR Newswire
- Article date:
- November 5, 2009
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BRISBANE, Calif., Nov. 5 /PRNewswire-FirstCall/ -- InterMune, Inc. today announced additions to its senior leadership team to prepare for the potential commercialization of pirfenidone in the United States and Europe.
The company announced yesterday that it had submitted a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market pirfenidone for the treatment of IPF. The company expects to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) in the first quarter of 2010. Pirfenidone has been granted Orphan Drug and Fast Track designation by the FDA, and also has been granted ...