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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 ...
Original Article: FDA Rejects Second Vernalis Cough/Cold CandidateNEXT ARTICLE
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...
Collaborations in biotechnology
Commercial and academic collaborations are used throughout the biotechnology and pharmaceutical sector to enhance research and product development. Collaborations can take the form of research and evaluation agreements, licensing, partnerships etc. ...