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) |
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| 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 |
| Sponsor: |
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. |
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