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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: misoprostol
Date Designated: 01/10/2005
Orphan Designation: Treatment of intrauterine fetal death not accompanied by complete expulsion of the products of conception in the second and third trimesters of pregnancy.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Gynuity Health Projects, LLC
15 East 26th Street
New York, New York 10010
United States

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

*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.