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Pristiq Approval History

  • FDA approved: Yes (First approved February 29th, 2008)
  • Brand name: Pristiq
  • Generic name: desvenlafaxine
  • Dosage form: Extended-Release Tablets
  • Company: Wyeth Pharmaceuticals
  • Treatment for: Depression, Major Depressive Disorder

Pristiq (desvenlafaxine) is a serotonin-norepinephrine reuptake inhibitor (SNRI) approved for the treatment for adult patients with major depressive disorder. Pristiq is also currently under review as a treatment for moderate-to-severe vasomotor symptoms associated with menopause.

Development History and FDA Approval Process for Pristiq

Mar  3, 2008Approval FDA Approves Pristiq for the Treatment of Adult Patients with MajorDepressive Disorder
Jul 24, 2007Wyeth Receives Approvable Letter from FDA for Pristiq for the Treatment of Vasomotor Symptoms Associated with Menopause
Jan 23, 2007Wyeth Receives Approvable Letter From FDA for Pristiq (Desvenlafaxine Succinate) for the Treatment of Major Depressive Disorder
Aug 29, 2006Re-formatted Data Submission Results in Extension of FDA Review for Desvenlafaxine Succinate
Aug 22, 2006FDA Cancels Advisory Committee Meeting to Review Desvenlafaxine Succinate Data for Major Depressive Disorder
Jun 26, 2006Wyeth Submits Two New Drug Applications for Women's Health Therapies
Dec 22, 2005Wyeth Submits New Drug Application for Desvenlafaxine Extended Release (DVS-233) for Depression

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