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