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Inrebic FDA Approval History

Last updated by Judith Stewart, BPharm on Nov 29, 2019.

FDA Approved: Yes (First approved August 16, 2019)
Brand name: Inrebic
Generic name: fedratinib
Dosage form: Capsules
Company: Celgene Corporation
Treatment for: Myelofibrosis

Inrebic (fedratinib) is a highly selective JAK2 inhibitor for the treatment of patients with myelofibrosis.

Development Timeline for Inrebic

DateArticle
Aug 16, 2019Approval  FDA Approves Inrebic (fedratinib) for the Treatment of Patients With Myelofibrosis
Jun  3, 2019Celgene Updated Analysis of Jakarta2 Fedratinib Study Shows Clinically Meaningful Responses in Patients Previously Treated for Myelofibrosis with Ruxolitinib
Mar  5, 2019U.S. FDA Grants Priority Review for Fedratinib New Drug Application in Myelofibrosis

Further information

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