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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: (1-{2-[(3S,4R)-1-[(3R,4R)-1-cyclopentyl-3-fluoro-4-(4-methoxyphenyl)pyrrolidine-3-carbonyl]-4-(methoxymethyl)pyrrolidin-3-yl]-5-(trifluoromethyl)phenyl}piperidine-4-caroxylic acid-phosphoric acid (1/1)
Date Designated: 06/08/2020
Orphan Designation: treatment of cutaneous variants of porphyria (which includes treatment and prevention of cutaneous manifestations of disease)
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Mitsubishi Tanabe Pharma Development America, Inc.
525 Washington Blvd
Suite 400
Jersey City, New Jersey 07310
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.