Vulvar and Vaginal Atrophy

• CLINICAL_TRIALS trial_result · 2015-12-14
  Clinical Trial Update: TXV13-01 Estradiol Vaginal Softgel Capsules in Treating Postmenopausal Women With Symptoms of Vulvar and Vaginal Atrophy [Phase 2]

  Phase 2 trial TXV13-01 assessed estradiol vaginal softgel capsules for postmenopausal vulvar and vaginal atrophy. The study has completed an…

• FDA approval · 2015-08-24
  FDA Approved: OSPHENA — Supplemental Application (Duchesnay USA, Inc.)

  FDA approved a supplemental application for OSPHENA (ospemifene) filed by Duchesnay USA, Inc.

• FDA approval · 2014-07-31
  FDA Approved: VIVELLE-DOT — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for VIVELLE-DOT (estradiol) from Sandoz Inc., updating the product labeling.

• EMA guidance · 2013-12-20
  The European Medicines Agency recommends that estradiol-containing creams Linoladiol N and Linoladiol HN remain available

  The EMA recommends that estradiol-containing creams Linoladiol N and Linoladiol HN remain available on the market.

• FDA approval · 2013-09-27
  FDA Approved: OSPHENA — Supplemental Application (Duchesnay USA, Inc.)

  The FDA approved a supplemental application for OSPHENA (ospemifene) submitted by Duchesnay USA, Inc. The exact changes to the labeling or i…

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• CLINICAL_TRIALS trial_result · 2013-09-02
  Clinical Trial Update: A Clinical Trial to Evaluate the Safety and Efficacy of Enjuvia 0.3 mg for the Treatment of Vulvovaginal Atrophy [Phase 3]

  A Phase 3 trial evaluating the safety and efficacy of Enjuvia 0.3 mg for vulvar and vaginal atrophy due to menopause has completed.

• CLINICAL_TRIALS trial_result · 2013-06-28
  Clinical Trial Update: A Clinical Study to Evaluate the Efficacy and Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women [Phase 2]

  Phase 2 clinical trial evaluated the efficacy and safety of ospemifene for vulvar and vaginal atrophy in postmenopausal women; results have …

• CLINICAL_TRIALS trial_result · 2013-06-28
  Clinical Trial Update: A Clinical Study to Evaluate Ospemifene in the Treatment of Vulvar and Vaginal Atrophy in Postmenopausal Women [Phase 3]

  This Phase 3 clinical trial evaluated ospemifene for vulvar and vaginal atrophy in postmenopausal women and has completed with results poste…

• CLINICAL_TRIALS trial_result · 2013-06-28
  Clinical Trial Update: Long-Term Safety of 30 mg and 60 mg Oral Daily Dose of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women With Intact Uterus [Phase 3]

  Phase 3 long-term safety study evaluating daily oral ospemifene at 30 mg and 60 mg for vulvar and vaginal atrophy in postmenopausal women wi…

• CLINICAL_TRIALS trial_result · 2013-06-28
  Clinical Trial Update: Long-Term Safety of Ospemifene 60 mg Oral Daily Dose for the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women Without a Uterus [Phase 3]

  Phase 3 long-term safety data for ospemifene 60 mg daily in postmenopausal women with vulvar and vaginal atrophy have been reported, with re…

• FDA approval · 2012-11-09
  FDA Approved: VAGIFEM — Supplemental Application (Novo Nordisk)

  FDA approved a supplemental application for Vagifem (estradiol) submitted by Novo Nordisk. The action typically relates to changes in labeli…

• FDA approval · 2011-10-28
  FDA Approved: CONJUGATED ESTROGENS — Supplemental Application (Prasco Laboratories)

  FDA has approved a supplemental NDA for Conjugated Estrogens (Estrogens, Conjugated) from Prasco Laboratories.

• FDA approval · 2011-05-17
  FDA Approved: VAGIFEM — Supplemental Application (Novo Nordisk)

  The FDA approved a supplemental application for Vagifem (estradiol) from Novo Nordisk, indicating updated labeling for the product.

• FDA approval · 2007-10-11
  FDA Approved: DELESTROGEN — Supplemental Application (Par Health USA, LLC)

  The FDA approved a supplemental application for Delestrogen (estradiol valerate) from Par Health USA, LLC, resulting in updated labeling for…

• FDA approval · 2006-12-15
  FDA Approved: ELESTRIN — Original Application (Viatris Specialty LLC)

  FDA approved ELESTRIN (estradiol) via an original NDA; indicates estrogen replacement therapy for menopausal symptoms and related indication…

• FDA approval · 2006-07-26
  FDA Approved: PREMARIN VAGINAL — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)

  FDA approved a supplemental application for Premarin Vaginal (conjugated estrogens) submitted by Wyeth Pharmaceuticals (a subsidiary of Pfiz…