Complete Response letter for CCP 07 a cough cold treatment being developed for Vernalis plc by partner Tris Pharma.
Vernalis plc announces that the FDA has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for CCP 07 , a cough cold treatment being developed by partner Tris Pharma.
A CRL is issued by the FDA when it has completed its review of an NDA and questions remain that preclude its approval at this time. The CRL did not raise any concerns with the formulation or pharmacokinetic profile of CCP 07 but did identify outstanding items that need to be addressed prior to the resubmission and approval of the NDA.
Comment: Tris Pharma is developing up to six unique extended release equivalents to existing immediate release prescription cough cold treatments for the US market under an exclusive licensing and collaboration agreement signed with Vernalis in February 2012. CCP-07 is the second product from this pipeline to be accepted for full NDA review following Tuzistra, which was approved by the FDA and subsequently launched by Vernalis in 2015.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
3 mins