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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: parathyroid hormone
Trade Name: Natpara
Date Designated: 08/31/2007
Orphan Designation: Treatment of hypoparathyroidism
Orphan Designation Status: Designated/Approved
Takeda Pharmaceuticals USA, Inc.
95 Hayden Avenue
Lexington, Massachusetts 02421
United States

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

Marketing approved:

1 Generic Name: parathyroid hormone
Trade Name: Natpara
Marketing Approval Date: 01/23/2015
Approved Labeled Indication: An adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism
Exclusivity End Date: 01/23/2022 
Exclusivity Protected Indication* :  An adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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