Osteoporosis

• FDA approval · 2015-03-26
  FDA Approved: ACTONEL — Supplemental Application (Allergan, Inc.)

  The FDA approved a supplemental application for Actonel (risedronate sodium) submitted by Allergan, expanding its labeling for additional os…

• FDA approval · 2015-03-26
  FDA Approved: ATELVIA — Supplemental Application (Allergan, Inc.)

  FDA approved a supplemental application for Atelvia (risendronate sodium) filed by Allergan, expanding/ updating the product's labeling thro…

• FDA approval · 2015-02-26
  FDA Approved: PROLIA — Supplemental Application (Amgen, Inc)

  FDA approved a supplemental application for PROLIA (denosumab) from Amgen, resulting in updates to the product labeling.

• FDA approval · 2015-02-02
  FDA Approved: MIACALCIN — Supplemental Application (Mylan Institutional LLC)

  The FDA approved a supplemental application for Miacalcin (calcitonin salmon) submitted by Mylan Institutional LLC.

• FDA approval · 2015-01-30
  FDA Approved: RECLAST — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for RECLAST (zoledronic acid) filed by Sandoz Inc., signaling a change to the product's labeling or …

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• FDA approval · 2014-12-19
  FDA Approved: ESTRADIOL — Original Application (Mylan Pharmaceuticals Inc.)

  FDA approved an original application for a generic estradiol product from Mylan Pharmaceuticals.

• FDA approval · 2014-12-05
  FDA Approved: PROLIA — Supplemental Application (Amgen, Inc)

  FDA approved a supplemental application for PROLIA (denosumab) from Amgen, expanding its approved use.

• FDA approval · 2014-09-12
  FDA Approved: TERIPARATIDE — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for teriparatide submitted by Prasco Laboratories under NDA 021318.

• FDA approval · 2014-08-13
  FDA Approved: TERIPARATIDE — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for Teriparatide submitted by Prasco Laboratories.

• FDA approval · 2014-06-10
  FDA Approved: RISEDRONATE SODIUM — Original Application (Apotex Corp.)

  FDA approved Apotex Corp.'s original ANDA for risedronate sodium, a generic version of Actonel. The approval covers indications for treating…

• FDA approval · 2014-04-11
  FDA Approved: TERIPARATIDE — Supplemental Application (Prasco Laboratories)

  FDA approves a supplemental application for teriparatide submitted by Prasco Laboratories. This action expands access to teriparatide under …

• FDA approval · 2014-03-05
  FDA Approved: TERIPARATIDE — Supplemental Application (Prasco Laboratories)

  FDA approves a supplemental application for teriparatide submitted by Prasco Laboratories, establishing a generic version of the osteoporosi…

• FDA approval · 2013-12-23
  FDA Approved: FOSAMAX — Supplemental Application (Organon LLC)

  The FDA approved a supplemental application for Fosamax (alendronate sodium) submitted by Organon LLC.

• FDA approval · 2013-12-23
  FDA Approved: BINOSTO — Supplemental Application (Radius Health, Inc.)

  The FDA approved a supplemental application for BINOSTO (alendronate sodium) from Radius Health, Inc., resulting in changes to the product l…

• FDA approval · 2013-11-07
  FDA Approved: FOSAMAX PLUS D — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for FOSAMAX PLUS D (alendronate sodium and cholecalciferol) submitted by Organon LLC.

• FDA approval · 2013-09-23
  FDA Approved: ZOLEDRONIC ACID — Original Application (Sagent Pharmaceuticals)

  FDA approves a generic zoledronic acid injection from Sagent Pharmaceuticals under ANDA 202828, granting approval to market the product for …

• FDA approval · 2013-08-30
  FDA Approved: TERIPARATIDE — Supplemental Application (Prasco Laboratories)

  FDA has approved a supplemental application for teriparatide submitted by Prasco Laboratories, related to the NDA 021318 product.

• FDA approval · 2013-08-23
  FDA Approved: PROLIA — Supplemental Application (Amgen, Inc)

  FDA approved a supplemental application for PROLIA (denosumab) submitted by Amgen, Inc., resulting in updated labeling for osteoporosis indi…

• FDA approval · 2013-08-02
  FDA Approved: TERIPARATIDE — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for teriparatide submitted by Prasco Laboratories, authorizing its marketing.

• FDA approval · 2013-07-15
  FDA Approved: ALENDRONATE SODIUM — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  The FDA approved a supplemental application for alendronate sodium, manufactured by Amneal Pharmaceuticals of New York LLC. This action appr…

• FDA approval · 2013-06-03
  FDA Approved: ZOLEDRONIC ACID — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approves Hikma Pharmaceuticals USA Inc.'s original application for a generic zoledronic acid injectable product.

• FDA approval · 2013-04-19
  FDA Approved: ACTONEL — Supplemental Application (Allergan, Inc.)

  FDA approved Allergan's supplemental application for Actonel (risendronate sodium).

• FDA approval · 2013-04-19
  FDA Approved: FOSAMAX PLUS D — Supplemental Application (Organon LLC)

  The FDA approved a supplemental NDA for Fosamax Plus D (alendronate sodium and cholecalciferol) from Organon LLC. The action approves a supp…

• FDA approval · 2013-04-19
  FDA Approved: ATELVIA — Supplemental Application (Allergan, Inc.)

  FDA approved a supplemental application for Atelvia (risendronate sodium) submitted by Allergan, Inc.

• FDA approval · 2013-04-19
  FDA Approved: BINOSTO — Supplemental Application (Radius Health, Inc.)

  The FDA has approved a supplemental application for BINOSTO (alendronate sodium) from Radius Health, Inc. The approval updates the labeling …