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Clolar FDA Approval History

FDA Approved: Yes (First approved December 28, 2004)
Brand name: Clolar
Generic name: clofarabine
Dosage form: for Intravenous Infusion
Company: Genzyme Corp.
Treatment for: Acute Lymphoblastic Leukemia

Clolar (clofarabine) is a purine nucleoside anti-metabolite indicated for the treatment of children with refractory or relapsed acute lymphoblastic leukemia (ALL).

Development Timeline for Clolar

Dec 28, 2004Approval Clolar Genzyme Corp. - Treatment for Leukemia in Children
Dec  1, 2004FDA Advisory Committee Recommends Accelerated Clofarabine Approval for Most Common Pediatric Leukemia; FDA to Make Approval Decision by End of Year
Sep 28, 2004ILEX's Clofarabine Scheduled For FDA Advisory Committee Review; ODAC to Review Pivotal Data for Pediatric Acute Leukemia
Aug 24, 2004ILEX Updates Clofarabine NDA with Encouraging Results; Additional Patient Data Resets FDA Action Date
Jul 21, 2004FDA Will Grant ILEX's Clofarabine Additional Six-Month Pediatric Exclusivity; Incentive Provides Extended Patent Protection Upon Marketing Approval
Jun  3, 2004FDA Begins Priority Review of ILEX NDA for Clofarabine in Pediatric Acute Leukemia; Filing Acceptance Indicates Start of Official Review Period
Mar 31, 2004ILEX Completes New Drug Application for Clofarabine; Filing Offers Hope to Children with Most Difficult-to-Treat Leukemias

Further information

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