Genitourinary Syndrome of Menopause

• 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 · 2011-04-22
  FDA Approved: PREMARIN VAGINAL — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)

  FDA approved a supplemental application for Premarin Vaginal (conjugated estrogens) from Wyeth Pharmaceuticals (Pfizer) to update the labeli…

• FDA approval · 2009-11-25
  FDA Approved: VAGIFEM — Supplemental Application (Novo Nordisk)

  FDA approved a supplemental application for Vagifem (estradiol) from Novo Nordisk. It involves changes to the product's labeling under the s…

• FDA approval · 2009-05-20
  FDA Approved: FEMRING — Supplemental Application (Millicent US, Inc.)

  The FDA approved a supplemental application for FEMRING (estradiol acetate) from Millicent US, Inc.

• FDA approval · 2008-08-25
  FDA Approved: ESTRING — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  The FDA approved a supplemental application for ESTRING (estradiol) submitted by Pfizer Laboratories Div Pfizer Inc.

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• FDA approval · 2008-04-11
  FDA Approved: EVAMIST — Supplemental Application (Padagis US LLC)

  FDA approves a supplemental NDA for EVAMIST (estradiol) by Padagis US LLC.

• 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.

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

  The FDA approved a supplemental application for PREMARIN VAGINAL (conjugated estrogens) submitted by Wyeth Pharmaceuticals (Pfizer). This ac…

• FDA approval · 2007-07-27
  FDA Approved: EVAMIST — Original Application (Padagis US LLC)

  The FDA approves Evamist (estradiol) from Padagis US LLC under NDA 022014 for the treatment of vasomotor symptoms associated with menopause.