FDA issues a Complete Response Letter on CCP-08 NDA
The US Food and Drug Administration has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for CCP-08, a prescription cough cold treatment.
News of the setback saw shares of UK-based Vernalis (LSE: VER) plunge 9.14% to 17.21 pence shortly after the market opened this morning, having dropped as low as 16.00 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. This CRL indicated that the outstanding items which resulted in the CRL for CCP-07, also a long-acting cough-cold formulation, remain and that they need to be addressed prior to the resubmission and approval of both NDAs, Vernalis explained.
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