Esbriet® (pirfenidone) receives FDA approval under 'breakthrough status'; Diplomat to distribute

October 16, 2014 1:57 PM

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FLINT, Mich., Oct. 16, 2014 /PRNewswire/ -- Diplomat, the nation's largest independent specialty pharmacy, announced today that it has a contract to distribute Esbriet (pirfenidone), which was approved Oct. 15, 2014 by the U.S. Food and Drug Administration for the treatment of idiopathic pulmonary fibrosis. In addition to the breakthrough therapy designation, Esbriet was also granted the orphan drug designation and received priority review.

Manufactured by InterMune Inc., Esbriet is an orally active, anti-fibrotic agent that inhibits the synthesis of TGF-beta, a chemical mediator that plays a key role in fibrosis, or scarring, in the lungs. Esbriet will be available in 260mg, 270-capsule bottles. Esbriet was approved by the FDA under t...

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