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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  fixed dose combination of methimazole and liothyronine
Date Designated:  03/06/2017
Orphan Designation:  Treatment of brain metastases in patients with primary lung cancer
Orphan Designation Status:  Designated
FDA Orphan Approval Status:  Not FDA Approved for Orphan Indication
Musli Thyropeutics Ltd.
6 Hagefen Street
P. O. Box 529
Zur Moshe

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.