Vasomotor Symptoms

• FDA approval · 2025-04-29
  FDA Approved: DIVIGEL — Supplemental Application (Vertical Pharmaceuticals, LLC)

  The FDA approved a supplemental application for Divigel (estradiol) from Vertical Pharmaceuticals, LLC. The approval updates the product lab…

• FDA approval · 2024-08-02
  FDA Approved: LYLLANA — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for LYLLANA (estradiol) submitted by Amneal Pharmaceuticals LLC.

• FDA approval · 2024-02-15
  FDA Approved: BIJUVA — Supplemental Application (Mayne Pharma)

  The FDA approved a supplemental application for BIJUVA, a combination of estradiol and progesterone, submitted by Mayne Pharma. The approval…

• FDA approval · 2015-07-23
  FDA Approved: DUAVEE — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)

  FDA approved a supplemental application for Duavee (conjugated estrogens/bazedoxifene) to update the labeling, potentially expanding its app…