Vernalis says US FDA accepts CCP-08 for full review

21st Dec 2016 13:03

(ShareCast News) - Vernalis and Tris Pharma said the US Food and Drug Administration (FDA) has accepted the CCP-08 New Drug Application (NDA) for full review.This triggered a milestone payment from AIM-quoted Vernalis to Tris. The FDA had set a Prescription Drug User Fee Act (PDUFA) target date for conclusion of its review of 4 August, 2017. Vernalis said that, under the exclusive licensing and collaboration agreement announced in 2012, Tris was developing up to six unique extended-release equivalents to existing immediate-release prescription cough cold treatments for the US market.It added that CCP-08 was the third product from this pipeline to be accepted for full NDA review.The first product, Tuzistra XR, was approved by the FDA in April 2015 and was launched by Vernalis in September 2015 by a dedicated sales force.The second product, CCP-07, was accepted for full review by FDA in September 2016 and has a PDUFA date of 20 April 2017.At about 13:01 GMT, shares in Vernalis were up 3.32% to 35p each.