Osteoporosis

• FDA approval · 2011-08-10
  FDA Approved: TERIPARATIDE — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application for teriparatide filed by Prasco Laboratories, expanding the regulatory status of the product un…

• FDA approval · 2011-07-07
  FDA Approved: ALENDRONATE SODIUM — Supplemental Application (EXELAN PHARMACEUTICALS INC.)

  FDA approved a supplemental application for alendronate sodium submitted by Exelan Pharmaceuticals.

• FDA approval · 2011-07-01
  FDA Approved: FOSAMAX PLUS D — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for Fosamax Plus D (alendronate sodium and cholecalciferol) by Organon LLC.

• FDA approval · 2011-04-06
  FDA Approved: ALENDRONATE SODIUM — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for ALENDRONATE SODIUM from Aurobindo Pharma Limited, indicating approval of a supplemental submissi…

• FDA approval · 2011-04-01
  FDA Approved: ALENDRONATE SODIUM — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved a supplemental application for alendronate sodium filed by Amneal Pharmaceuticals of New York LLC. This action updates the regu…

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• FDA approval · 2011-02-15
  FDA Approved: ALENDRONATE SODIUM — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for Alendronate sodium filed by Aurobindo Pharma Limited.

• FDA approval · 2011-01-25
  FDA Approved: FOSAMAX — Supplemental Application (Organon LLC)

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

• FDA approval · 2011-01-25
  FDA Approved: FOSAMAX PLUS D — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for Fosamax Plus D (alendronate sodium with cholecalciferol) from Organon LLC.

• FDA approval · 2011-01-25
  FDA Approved: RECLAST — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for RECLAST (zoledronic acid) filed by Sandoz Inc.

• FDA approval · 2010-11-18
  FDA Approved: PROLIA — Supplemental Application (Amgen, Inc)

  FDA approved a supplemental application for PROLIA (denosumab) filed by Amgen.

• FDA approval · 2010-08-24
  FDA Approved: ALENDRONATE SODIUM — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for alendronate sodium from Aurobindo Pharma Limited, enabling the marketing of a generic produc…

• FDA approval · 2010-08-03
  FDA Approved: VITAMIN D — Original Application (Strides Pharma Science Limited)

  FDA approves Strides Pharma Science Limited's generic vitamin D product ergocalciferol under an Original Application (ANDA 090455).

• FDA approval · 2010-03-01
  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 · 2010-01-19
  FDA Approved: ESTRADIOL VALERATE — Original Application (American Regent, Inc.)

  FDA approved Estradiol Valerate under an Original Application (ANDA 090920), granting a new generic product status to American Regent, Inc.

• FDA approval · 2009-10-20
  FDA Approved: ALENDRONATE SODIUM — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved a supplemental application for ALENDRONATE SODIUM from Amneal Pharmaceuticals of New York LLC, authorizing an additional regula…

• FDA approval · 2009-09-24
  FDA Approved: ALENDRONATE — Original Application (Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd.)

  FDA approved Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd.'s generic alendronate (alendronate sodium tablets) via an Original Applicat…

• FDA approval · 2009-07-22
  FDA Approved: TERIPARATIDE — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application for teriparatide submitted by Prasco Laboratories, indicating changes to the product's labeling …

• FDA approval · 2009-06-08
  FDA Approved: CALCITONIN SALMON — Original Application (Endo USA, Inc.)

  FDA approved Endo USA, Inc.'s Original Application for Calcitonin Salmon (generic), confirming a generic product for the drug. The approval …

• FDA approval · 2008-10-08
  FDA Approved: FOSAMAX — Supplemental Application (Organon LLC)

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

• FDA approval · 2008-08-04
  FDA Approved: ALENDRONATE SODIUM — Original Application (EXELAN PHARMACEUTICALS INC.)

  FDA approved the original application for alendronate sodium (Exelan Pharmaceuticals Inc.), making this generic osteoporosis therapy availab…

• FDA approval · 2008-08-04
  FDA Approved: ALENDRONATE SODIUM — Original Application (Aurobindo Pharma Limited)

  FDA approves the original application for alendronate sodium from Aurobindo Pharma Limited as a generic therapy.

• FDA approval · 2008-06-25
  FDA Approved: TERIPARATIDE — Supplemental Application (Prasco Laboratories)

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

• FDA approval · 2008-04-22
  FDA Approved: ACTONEL — Supplemental Application (Allergan, Inc.)

  FDA approved a supplemental application for Actonel (risedronate sodium) submitted by Allergan, Inc., resulting in an approved update to the…

• FDA approval · 2008-02-28
  FDA Approved: TERIPARATIDE — Supplemental Application (Prasco Laboratories)

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

• FDA approval · 2007-10-05
  FDA Approved: RISEDRONATE SODIUM — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approves Teva's risendronate sodium generic from an Original Application (ANDA 077132), enabling marketing of a risendronate sodium tabl…