U.S. Food and Drug Administration recently issued the following announcement.
Isocarboxazid Tablets
Status: Currently in Shortage
»Date first posted: 05/15/2018
»Therapeutic Categories: Psychiatry
Validus Pharmaceuticals LLC (Revised 02/26/2019)
Company Contact Information:
866-982-5438 (1-866-9VALIDUS)
Presentation: 10mg (NDC 30698-032-01)
Availability and Estimated Shortage Duration: Due to the current critical shortage of Isocarboxazid Tablets in the United States (US) market, Validus Pharmaceuticals LLC is coordinating with the U.S. Food and Drug Administration (FDA) to increase the availability of Isocarboxazid Tablets. Validus has initiated temporary importation of another manufacturer’s Isocarboxazid Tablets into the U.S. market. This product is manufactured and marketed in Denmark by MediLink. MediLink's Marplan is commercially available under a new NDC 72604-032-01.
Related Information: Dear Healthcare Professional Letter
Shortage Reason (per FDASIA): Requirements related to complying with good manufacturing practices
Original source can be found here.
