HEALTH CARE PROVIDER LETTER SECTION.
Temporary Importation of Marplan (iscarboxacid) Tablets to Address Critical Drug Shortage. IMPORTANT PRESCRIBING INFORMATIONDecember 20, 2018Subject: Temporary Importation of Marplan(R) (isocarboxacid) Tablets to Address Critical Drug ShortageDear Healthcare Professional,In order to address the critical shortage of Marplan(R) (isocarboxazid) 10 mg Tablets in the United States (US) market, Validus Pharmaceuticals LLC is coordinating with the U.S. Food and Drug Administration (FDA) to make Marplan available to our patients. Validus has initiated temporary importation of another manufacturers Marplan (isocarboxacid) into the U.S. market. This product is manufactured and marketed in Denmark by MediLink.At this time, no other entity except Validus Pharmaceuticals LLC is authorized by the FDA to import and distribute MediLinks Marplan (isocarboxacid) 10 mg Tablets in the United States. FDA has not approved MediLinks Marplan (isocarboxacid) 10 mg Tablets but does not object to its importation into the United States. Effective immediately, and during this temporary period, Validus will offer the following product:Product Name and Description Bottle Count NDC Code Manufacturer Marplan (isocarboxacid) 10 mg Tablets 56 tablets 72604-032-01 MediLinkIt is important to note the following:o The labeling is in Danish. MediLinks Marplan (isocarboxacid) 10 mg Tablets labeling, with the exception of the product name Marplan, will appear in Danish. There are key differences in the labeling between Validus Marplan and Medilinks Marplan. side by side comparison of the FDA approved Marplan (isocarboxazid) Prescribing Information and the imported Marplan (isocarboxacid) product information is included at the end of this letter.o The tablets have different appearance. MediLinks Marplan (isocarboxacid) 10 mg tablets are dull pink in color whereas Validus Marplan (isocarboxazid) 10 mg tablets are peach-colored. MediLinks Marplan 10 mg tablets are imprinted with CL 3M3 whereas Validus Marplan 10 mg tablets are imprinted with Marplan and 10 on one side. Please refer to the Product Comparison table at the end of this letter for details and images.o The barcode may not register accurately in the U.S. scanning systems. Institutions should manually input the product into their systems and confirm that the barcode Marplan DHCP Letter Page of 22 systems do not provide incorrect information when the product is scanned. Alternative procedures should be followed to assure that the correct drug product is being used and administered to individual patients.To order, or if you have any questions about MediLinks Marplan, please contact Validus Customer Service by phone at 1-866-982-5438 or by e-mail at infovaliduspharma.com.To report Adverse Events or Quality Problems among patients who have received MediLinks Marplan, please contact Validus at 1-866-982-5438 or by e-mail at infovaliduspharma.com. Adverse events or quality problems may also be reported to FDAs MedWatch Adverse reporting Program either online, by regular mail, or by fax:o Complete and submit the report Online: www.fda.gov/medwatch/report.htmo Regular Mail or Fax: Download form www.fda.gov/Medwatch/getforms.htm or call 1- 800-332-1088 to request reporting form. Complete and return the form to the address on the pre-addressed form, or submit it by fax to 1-800-FDA-0178 (1-800- 332-1078).If you have any questions about the information contained in this letter or the safe and effective use of MediLinks Marplan (isocarboxacid) 10mg Tablets, please contact Validus at 1-866-982- 5438 or by e-mail at infovaliduspharma.com.Sincerely,Gina WalljasperSr. Director Regulatory and Quality OperationsValidus Pharmaceuticals LLC.
Citing DrugCentral © 2023. License
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
Principal Display Panel Marplan (isocarboxacid) 10mg Tablets. Marplan 10 mg is round and flat, pink tablet with break line on one side and labeled CL 3M3 on the other side.. Primary Label.
Citing DrugCentral © 2023. License