Teva's Copaxone NDA accepted by FDA for treatment of MS; follow-on Phase III data supportive.
Executive Summary
TEVA COPAXONE NDA ACCEPTED BY FDA for filing, Teva announced Oct. 30. The company resubmitted the NDA Oct. 11 for copolymer-1 for multiple sclerosis with additional chemical information on standards and markers requested by FDA after the agency sent a "refuse to file" letter for the original NDA shortly after it was submitted June 15. Teva disclosed the NDA's status Aug. 21 ("The Pink Sheet" Aug. 28, In Brief).