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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: 6-fluoro-7-(2-fluoro-6-hydroxyphenyl)-(1M)-1-[4-methyl-2-(propan-2-yl)pyridin-3-yl]-4-[(2S)-2- methyl-4-(prop-2-enoyl)piperazin-1-yl]pyrido[2,3-d]pyrimidin-2(1H)-one
Date Designated: 05/23/2019
Orphan Designation: Treatment of KRAS (Kirsten rat sarcoma viral oncogene homolog) p.G12C-positive Colorectal Cancer.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Amgen Inc.
1 Amgen Center Drive
Mail Stop 27-3-A
Thousand Oaks, California 91320
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.
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