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Mekinist Approval History

  • FDA approved: Yes (First approved May 29th, 2013)
  • Brand name: Mekinist
  • Generic name: trametinib
  • Dosage form: Tablets
  • Company: GlaxoSmithKline
  • Treatment for: Melanoma, Metastatic

Mekinist (trametinib) is a kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test.

Development History and FDA Approval Process for Mekinist

Jan  9, 2014Approval GSK Gains Accelerated FDA Approval for Combination Use of Mekinist (trametinib) and Tafinlar (dabrafenib)
May 29, 2013Approval FDA Approves Mekinist (trametinib) for Advanced Melanoma
May  1, 2013Regulatory Update: Trametinib US PDUFA Date Extended to 3 September 2013

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