Postmenopausal Osteoporosis

• 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.

• FDA label_change · 2014-12-02
  FDA Approved: ACTONEL — Supplemental Application (Allergan, Inc.)

  FDA approved a supplemental application for ACTONEL (risendronate sodium) from Allergan, Inc., updating the product labeling.

• FDA label_change · 2013-08-02
  FDA Approved: BINOSTO — Supplemental Application (Radius Health, Inc.)

  The FDA approved a supplemental application for BINOSTO (alendronate sodium) from Radius Health, updating the product labeling.

• FDA label_change · 2013-04-24
  FDA Approved: VIVELLE-DOT — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for VIVELLE-DOT (estradiol) from Sandoz Inc, resulting in updated labeling.

• FDA label_change · 2011-01-25
  FDA Approved: ACTONEL — Supplemental Application (Allergan, Inc.)

  FDA approved a supplemental application for Actonel (risendronate sodium) filed by Allergan, Inc., to update the labeling related to its app…

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• FDA label_change · 2009-12-31
  FDA Approved: ACTONEL — Supplemental Application (Allergan, Inc.)

  FDA approved Allergan's supplemental NDA for Actonel (risendronate sodium) to update the labeling, potentially adding or revising indication…

• FDA label_change · 2007-03-28
  FDA Approved: MENOSTAR — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)

  FDA page indicates a supplemental application for Menostar (estradiol) by Bayer HealthCare Pharmaceuticals Inc., likely seeking changes to t…

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

  FDA approved a supplemental application for PREMARIN (conjugated estrogens), resulting in changes to the product labeling.