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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: peginterferon alfa-2b
Trade Name: Sylatron
Date Designated: 04/09/2008
Orphan Designation: Treatment of malignant melanoma stages IIb through IV.
Orphan Designation Status: Designated/Approved
Merck, Sharpe & Dohme Corp.
1 Merck Drive
Whitehouse Station, New Jersey 08889
United States

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

Marketing approved:

1 Generic Name: peginterferon alfa-2b
Trade Name: Sylatron
Marketing Approval Date: 03/29/2011
Approved Labeled Indication: Adjuvant treatment of melanoma with microscopic or gross nodal involvement within 84 days of definitive surgical resection including complete lymphadenectomy
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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