Vernalis says FDA accepts CCP-07 NDA for full review
Source - SMW
Vernalis and Tris Pharma said the US Food and Drug Administration (FDA) has accepted the CCP-07 New Drug Application (NDA) 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 20 April 2017.
Under the exclusive licensing and collaboration agreement announced in February 2012, Tris is developing up to six unique extended release equivalents to existing immediate release prescription cough cold treatments for the US market.
CCP-07 is the second product from this pipeline to be accepted for full NDA review. The first product, TuzistraXR, was approved by the FDA in April 2015 and was launched by Vernalis in September 2015 by a dedicated sales force.