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FDA Rejects Second Vernalis Cough/Cold Candidate

06:58 EDT 7 Aug 2017 | Genetic Engineering News

Vernalis acknowledged today that its New Drug Application (NDA) for CCP-08 has been rejected by the FDA—the second time in four months that the agency has turned down applications by the company for its cough cold treatment candidates. The company said it has received a Complete Response Letter (CRL) asking it to address similar issues to those that precluded the agency from approving another Vernalis cough cold treatment candidate, CCP-07—without disclosing those issues. “Unfortunately, the outstanding items that resulted in a CRL for CCP-07 could not be addressed in time to avoid the same outcome for CCP-08,” Vernalis CEO Ian Garland said in a statement. “The approval of both CCP-08 and CCP-07 are of the utmost importance to Vernalis, and we are working closely with our partner Tris Pharma and the FDA to resubmit both NDAs as quickly as possible,” Garland added. “We look forward to providing ...

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