Postmenopausal Osteoporosis

• FDA approval · 2008-11-17
  FDA Approved: CALCITONIN SALMON — Original Application (Apotex Corp.)

  FDA approved Apotex Corp.'s original ANDA for Calcitonin Salmon, authorizing a generic version of the drug for its approved uses.

• FDA approval · 2008-10-30
  FDA Approved: EVAMIST — Supplemental Application (Padagis US LLC)

  The FDA approved a supplemental application for EVAMIST, a transdermal estradiol product, under Padagis US LLC.

• 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.

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• 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 · 2008-03-03
  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 · 2008-02-28
  FDA Approved: TERIPARATIDE — Supplemental Application (Prasco Laboratories)

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

• FDA approval · 2008-02-06
  FDA Approved: ALENDRONATE SODIUM — Original Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved the original ANDA for Alendronate Sodium (generic) from Amneal Pharmaceuticals of New York LLC, expanding access for treatment …

• FDA approval · 2007-10-11
  FDA Approved: DELESTROGEN — Supplemental Application (Par Health USA, LLC)

  The FDA approved a supplemental application for Delestrogen (estradiol valerate) from Par Health USA, LLC, resulting in updated labeling for…

• FDA approval · 2007-04-26
  FDA Approved: FOSAMAX PLUS D — Supplemental Application (Organon LLC)

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

• FDA approval · 2007-04-16
  FDA Approved: RECLAST — Original Application (Sandoz Inc)

  FDA approves Sandoz's RECLAST (zoledronic acid) original application for osteoporosis-related indications, including postmenopausal osteopor…

• FDA approval · 2006-12-28
  FDA Approved: FOSAMAX — Supplemental Application (Organon LLC)

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

• FDA approval · 2006-12-15
  FDA Approved: ELESTRIN — Original Application (Viatris Specialty LLC)

  FDA approved ELESTRIN (estradiol) via an original NDA; indicates estrogen replacement therapy for menopausal symptoms and related indication…

• FDA approval · 2006-08-11
  FDA Approved: ACTONEL — Supplemental Application (Allergan, Inc.)

  FDA approves a supplemental application for Actonel (risedronate sodium) from Allergan, Inc., indicating an approved update to its labeling/…