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Valchlor Approval History

  • FDA approved: Yes (First approved August 23rd, 2013)
  • Brand name: Valchlor
  • Generic name: mechlorethamine
  • Dosage form: Topical Gel
  • Company: Ceptaris Therapeutics, Inc.
  • Treatment for: Mycosis Fungoides

Valchlor (mechlorethamine) gel an alkylating agent indicated for the topical treatment of Stage IA and IB mycosis fungoides‐type cutaneous T‐cell lymphoma.

Development History and FDA Approval Process for Valchlor

Aug 26, 2013Approval Ceptaris Receives FDA Approval for Valchlor (mechlorethamine) Gel for the Treatment of Mycosis Fungoides-Type Cutaneous T-Cell Lymphoma
Mar  8, 2013Ceptaris Resubmits New Drug Application (NDA) to FDA for Proprietary Gel Formulation of Mechlorethamine Hydrochloride
Oct  4, 2011FDA Accepts Filing of New Drug Application (NDA) for Yaupon's Proprietary Gel Formulation of Mechlorethamine Hydrochloride
Jul 28, 2011Yaupon Therapeutics, Inc. Submits New Drug Application for Proprietary Gel Formulation of Mechlorethamine Hydrochloride

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