FDA delays approval of Vernalis' CCP-07 NDA

The US Food and Drug Administration has issued a complete response letter (CRL) regarding the New Drug Application for CCP-07, a long-acting cough-cold formulation for UK-based Vernalis (LSE: VER), with the news sending the firm’s shares down 12.3% to 21.60 pence by mid-morning, having plunged as low as 20.00 pence.

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.

“We remain committed to the approval of CCP-07 and will work closely with the FDA to resubmit the NDA as quickly as possible," said Ian Garland, chief executive of Vernalis