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Brisdelle Approval History

  • FDA approved: Yes (First approved June 28th, 2013)
  • Brand name: Brisdelle
  • Generic name: paroxetine mesylate
  • Dosage form: Capsules
  • Company: Noven Pharmaceuticals, Inc.
  • Treatment for: Postmenopausal Symptoms

Brisdelle (paroxetine mesylate) is a low-dose selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of moderate to severe vasomotor symptoms associated with menopause.

Development History and FDA Approval Process for Brisdelle

Jun 28, 2013Approval FDA Approves Brisdelle - First Non-Hormonal Treatment for Hot Flashes Associated with Menopause
Mar  6, 2013Noven Announces FDA Advisory Committee Vote on Investigational Low-Dose Mesylate Salt of Paroxetine (LDMP) for Vasomotor Symptoms Associated with Menopause
Nov 14, 2012FDA Accepts Noven's NDA For An Investigational Nonhormonal Therapy For Menopausal Vasomotor Symptoms
Aug 29, 2012Noven Submits New Drug Application for Investigational Non-Hormonal Therapy for Menopausal Vasomotor Symptoms

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