Marplan® (isocarboxazid) 10 mg Tablets is currently on FDA’s Drug Shortage List. In order to address the critical shortage of Marplan® in the United States (U.S.) market, Validus Pharmaceuticals LLC has coordinated with the U.S. Food and Drug Administration (FDA) to make Marplan® available to patients in the U.S. who are in desperate need of relief from their illness. Validus has imported another manufacturer’s Marplan (isocarboxacid) for the U.S. market. This product is manufactured and marketed in Denmark by MediLink.
At this time, Validus Pharmaceuticals LLC is the only entity authorized by the FDA to import and distribute MediLink’s Marplan (isocarboxacid) 10 mg Tablets in the U.S. FDA has not approved MediLink’s Marplan (isocarboxacid) 10 mg Tablets but does not object to its importation and distribution in the U.S.
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Validus is in the process of transferring the manufacture of its Marplan® to a new site in the U.S. Upon successful completion and FDA approval, Validus will resume the distribution of the U.S. manufactured Marplan® (isocarboxazid) 10 mg Tablets.
For more information, please refer to the DHCP Letter at www.marplan.com.
About Validus Pharmaceuticals
Validus Pharmaceuticals LLC is a Parsippany, New Jersey-based specialty pharmaceutical company focused on the acquisition, reformulation, and marketing of FDA-approved prescription products that satisfy unmet clinical needs. To fulfill this mission, Validus seeks out and acquires marketed products that have well established safety profiles as well as significant clinical benefits.
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