FDA Accepts New Drug Application for Triangle HIV Drug Coviracil
Durham, N.C.-based Triangle Pharmaceuticals announced on Monday that the FDA has accepted its New Drug Application for the antiretroviral drug Coviracil, Reuters reports (Reuters, 11/4). According to Triangle, the acceptance of the application indicates that the application is "sufficiently complete for review" (Dow Jones News, 11/4). "We are very pleased with this notification," Daniel Welch, Triangle chair and CEO, said, adding that the drug, a nucleoside reverse transcriptase inhibitor, could be approved for marketing in the United States as soon as the third quarter of 2003. "We believe, once approved, Coviracil will offer patients and physicians an important new medicine for the management of HIV disease," Welch said. Triangle plans to apply for permission by the end of the year to market the drug in Europe, according to a Triangle release (Triangle Pharmaceuticals release, 11/4)This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.