Date: 2017-08-07
Type of information: Refusal of a Market Autorisation in the US
Product name: CCP-08
Compound:
Therapeutic area: Respiratory diseases
Action mechanism:
Company: Vernalis (UK) Tris Pharma (USA - NJ)
Disease: cough cold
Latest news:
- • On August 7, 2017, Vernalis announced that the FDA has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for CCP-08. 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. This CRL indicated that the outstanding items which resulted in the CRL for CCP-07 remain and that they need to be addressed prior to the resubmission and approval of both NDAs. Vernalis and Tris are now working closely to resubmit NDA as quickly as possible.
- • On December 21, 2016, Vernalis and Tris Pharma, announced that the FDA has accepted the CCP-08 New Drug Application 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 4 August 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-08 is 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.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization:
UE authorization:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
OTC status:
Other news:
Is general: Yes
