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CHARLES T. MEYER, M.D. wrote: > According to the FDA (CDER) web page Tolocapone was approved on June > 5. > > Approvable Original New Drug Applications > > Original Application #: 020697 > Approvable Date: 05-JUN-97 > Trade Name: TASMAR > Dosage Form: TABLET > Applicant: HOFFMANN LA ROCHE INC > Active Ingredient(s): TOLCAPONE > OTC/RX Status: RX If only t'were so. Look again. There is a definition of "Approvable Original New Drug Applications" further down in the web page: > Approvable Original New Drug Applications > An approvable letter indicates that FDA is prepared to approve the > application upon the satisfaction of conditions specified in the > approvable letter. Drug products which are the subject of > approvable letters may not be legally marketed until the firm has > satisfied the identified deficiencies, as well as any other > requirements that may be imposed by FDA, and has been notified in > writing that the application has been approved. Further information > on approvable NDAs is not subject to Freedom of Information (FOI) > release until applications are approved. The page is at http://www.fda.gov/cder/da/da.htm#June 1997