Vernalis plc and Tris Pharma, Inc. ("Tris") are pleased to announce that the U.S. Food and Drug Administration ("FDA") has confirmed that the New Drug Application ("NDA") for Tuzistra™ XR ("CCP-01") has been accepted for full review. This triggers a milestone payment from Vernalis to Tris.
The FDA has set a Prescription Drug User Fee Act (PDUFA) target date for conclusion of its review of 30 April 2015.
Under the exclusive licensing agreement announced in February 2012, Tris is developing, on behalf of Vernalis, up to six unique extended release equivalents to existing immediate release prescription cough cold treatments. Tuzistra™ XR represents the first product within this pipeline to reach NDA stage. The financial terms of this licensing deal are not disclosed.
Ian Garland, CEO of Vernalis commented "Today's announcement is in line with our target timelines and importantly Tuzistra™ XR remains on-track for potential launch ahead of the 2015-16 cough cold season".
Ketan Mehta, CEO of Tris commented, "FDA's acceptance of this NDA submission provides further momentum to our collective cough/cold strategy, with a focus on improving patient care".
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