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Folotyn Approval History

FDA Approved: Yes (First approved September 24, 2009)
Brand name: Folotyn
Generic name: pralatrexate
Dosage form: Injection
Company: Allos Therapeutics, Inc.
Treatment for: Non-Hodgkin's Lymphoma

Folotyn (pralatrexate) is a folate analogue metabolic inhibitor indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).

Development History and FDA Approval Process for Folotyn

DateArticle
Sep 25, 2009Approval FDA Approves Folotyn (pralatrexate) for Treatment of Peripheral T-cell Lymphoma
Sep  3, 2009Allos Therapeutics Announces FDA Advisory Committee Recommends Accelerated Approval of Folotyn (pralatrexate) for the Treatment of Patients with Relapsed or Refractory Peripheral T-cell Lymphoma
Aug 11, 2009Allos Therapeutics Announces FDA Advisory Committee to Review Pralatrexate for the Treatment of Patients with Relapsed or Refractory Peripheral T-cell Lymphoma
Mar 25, 2009Allos Therapeutics Submits New Drug Application for Pralatrexate for Patients with Relapsed or Refractory Peripheral T-cell Lymphoma

Further information

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