MARPLAN- isocarboxacid tablet

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

ISOCARBOXAZID (UNII: 34237V843T) (ISOCARBOXAZID - UNII:34237V843T)

متاح من:

MediLink A/S

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الوضع إذن:

Unapproved drug for use in drug shortage

خصائص المنتج

MARPLAN- ISOCARBOXACID TABLET
MEDILINK A/S
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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TEMPORARY IMPORTATION OF MARPLAN (ISCARBOXACID) TABLETS TO ADDRESS
CRITICAL DRUG SHORTAGE
IMPORTANT PRESCRIBING INFORMATION
December 20, 2018
Subject: Temporary Importation of Marplan® (isocarboxacid) Tablets to
Address Critical Drug
Shortage
Dear Healthcare Professional,
In order to address the critical shortage of Marplan® (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
manufacturer’s 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 MediLink’s Marplan (isocarboxacid) 10 mg Tablets in the
United States. FDA has not
approved MediLink’s 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 MediLink
It is important to note the following:
• The labeling is in Danish. MediLink’s 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 Medilink’s Marplan. A 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.
• The tablets have different appeara