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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: mebendazole
Trade Name: VERMOX 500 mg chewable tablets
Date Designated: 09/03/2014
Orphan Designation: Treatment of single or mixed gastrointestinal infestations by Trichuris trichiura (whipworm), Ascaris lumbricoides (large roundworm), and Ancylostoma duodenale and Nectar americanus (hookworm).
Orphan Designation Status: Designated/Approved
Janssen Pharmaceutical Research & Development, LLC
920 Route 202 South
Raritan, New Jersey 08869
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: mebendazole
Trade Name: VERMOX 500 mg chewable tablets
Marketing Approval Date: 10/19/2016
Approved Labeled Indication: treatment of patients one year of age and older withgastrointestinal infections caused by Ascaris lumbricoides (roundworm) and Trichuris trichiura (whipworm)
Exclusivity End Date: N/A  
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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