Vasomotor Symptoms of Menopause

• CLINICAL_TRIALS trial_result · 2025-09-17
  Clinical Trial Update: Paroxetine Versus Placebo for Vasomotor Symptom Management in Surgical Menopause [Phase 2]

  A Phase 2 randomized trial comparing paroxetine to placebo for vasomotor symptoms in women with surgical menopause has completed, according …

• FDA approval · 2025-04-22
  FDA Approved: PREMPRO — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)

  The FDA approved a supplemental application for Prempro (conjugated estrogens and medroxyprogesterone acetate) submitted by Wyeth/Pfizer to …

• FDA label_change · 2024-08-30
  FDA Approved: ESTRADIOL VAGINAL INSERTS — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved a supplemental labeling application for Estradiol vaginal inserts by Glenmark Pharmaceuticals. The approval indicates a labelin…

• FDA approval · 2024-02-15
  FDA Approved: ELESTRIN — Supplemental Application (Viatris Specialty LLC)

  FDA approved a supplemental application for ELESTRIN (estradiol) from Viatris Specialty LLC. The approval updates the labeling to incorporat…

• FDA label_change · 2024-02-15
  FDA Approved: VIVELLE-DOT — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for VIVELLE-DOT (estradiol) filed by Sandoz, resulting in labeling changes.

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• FDA approval · 2021-10-07
  FDA Approved: CLIMARA PRO — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Climara Pro (estradiol and levonorgestrel) submitted by Bayer, potentially updating labeling…

• FDA approval · 2019-02-05
  FDA Approved: DOTTI — Original Application (Amneal Pharmaceuticals LLC)

  The FDA approved Amneal's original application for DOTTI, a generic estradiol product, expanding availability of estrogen replacement therap…

• CLINICAL_TRIALS trial_result · 2018-03-01
  Clinical Trial Update: Transcranial Direct Current Stimulation (tDCS) in Vasomotor Symptoms of Menopause [NA]

  The clinical trial evaluating transcranial direct current stimulation for vasomotor symptoms of menopause (hot flashes) has completed.

• FDA approval · 2016-06-10
  FDA Approved: PAROXETINE — Original Application (Chartwell RX, LLC)

  The FDA approved Chartwell RX, LLC's original ANDA for paroxetine (paroxetine hydrochloride), establishing a generic version of the antidepr…

• CLINICAL_TRIALS trial_result · 2014-12-23
  Clinical Trial Update: Treatment of Hot Flushes in Asian Women With Ultra-low Dose Estradiol Patch [Phase 3]

  Phase 3 trial evaluating an ultra-low-dose estradiol patch for hot flashes in Asian women has completed.

• FDA approval · 2008-03-03
  FDA Approved: PREMARIN — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)

  FDA approved a supplemental application for Premarin (conjugated estrogens) from Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.