Federal Register Notice: FDA is revoking the temporary exemption that has allowed isocarboxazid products to remain on the market beyond the time limits scheduled for implementation of the Drug Efficacy Study. The agency announces the conditions for marketing this product for the indication now regarded as effective. Isocarboxazid, a monoamine oxidase inhibitor, is used in the treatment of depression. No other monoamine oxidase inhibitor remains exempt under the Paragraph XIV, Category XX exemption, and Category XX is now dissolved. Isocarboxazid is regarded as a new drug under section 201(p) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(p)), and an approved application, under section 505 of the act (21 U.S.C. 355), is required for marketing an isocarboxazid product. To view this notice, click here.
