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Turalio FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 6, 2020.

FDA Approved: Yes (First approved August 2, 2019)
Brand name: Turalio
Generic name: pexidartinib
Dosage form: Capsules
Company: Daiichi Sankyo
Treatment for: Tenosynovial Giant Cell Tumor

Turalio (pexidartinib) is a kinase inhibitor indicated for the treatment of symptomatic tenosynovial giant cell tumor (TGCT) in adults.

Development Timeline for Turalio

DateArticle
Aug  2, 2019Approval  FDA Approves Turalio (pexidartinib) for the Treatment of Symptomatic Tenosynovial Giant Cell Tumors (TGCT) in Adults
May 14, 2019FDA Oncologic Drugs Advisory Committee Votes in Favor of Daiichi Sankyo’s Pexidartinib for the Treatment of Select Patients with TGCT, a Rare, Debilitating Tumor
Feb  5, 2019FDA Grants Priority Review for Daiichi Sankyo’s New Drug Application for CSF1R Inhibitor Pexidartinib for Treatment of Patients with TGCT, a Rare, Debilitating Tumor
Jun  4, 2018Daiichi Sankyo Presents Phase 3 ENLIVEN Study of Pexidartinib, Demonstrating Statistically Significant Clinical Improvement Across Multiple Endpoints in Patients with Tenosynovial Giant Cell Tumor

Further information

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