Postmenopausal Osteoporosis

• FDA approval · 2014-06-04
  FDA Approved: PROLIA — Supplemental Application (Amgen, Inc)

  The FDA approved a supplemental application for PROLIA (denosumab) submitted by Amgen, Inc. This action expands regulatory approval for the …

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

  FDA approved a supplemental application for conjugated estrogens (Estrogens, Conjugated) filed by Prasco Laboratories, representing a regula…

• FDA approval · 2014-03-11
  FDA Approved: EVAMIST — Supplemental Application (Padagis US LLC)

  FDA approved a supplemental application for EVAMIST (estradiol) by Padagis US LLC.

• 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 · 2014-03-04
  FDA Approved: RALOXIFENE HYDROCHLORIDE — Original Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved Teva's raloxifene hydrochloride generic as an Original Application (ANDA), enabling a generic product for postmenopausal os…

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• FDA approval · 2014-02-27
  FDA Approved: ELESTRIN — Supplemental Application (Viatris Specialty LLC)

  FDA approved a supplemental application for ELESTRIN (estradiol) submitted by Viatris Specialty LLC.

• FDA approval · 2014-02-14
  FDA Approved: IBANDRONATE SODIUM — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Sun Pharmaceutical's ibandronate sodium as an original-application generic product for postmenopausal osteoporosis.

• 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 · 2013-10-03
  FDA Approved: DUAVEE — Original Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)

  The FDA approved DUAVEE (conjugated estrogens/bazedoxifene) from Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc., as an original appl…

• 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 · 2013-04-19
  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 …

• FDA approval · 2013-04-17
  FDA Approved: BINOSTO — Supplemental Application (Radius Health, Inc.)

  The FDA approved a supplemental application for BINOSTO (alendronate sodium) to expand its label for the treatment of osteoporosis.

• FDA approval · 2013-03-13
  FDA Approved: TERIPARATIDE — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application for Teriparatide submitted by Prasco Laboratories. The approval updates the drug’s labeling and/…

• FDA approval · 2013-03-08
  FDA Approved: IBANDRONATE SODIUM — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approved a supplemental application for ibandronate sodium submitted by Dr. Reddy's Laboratories Limited.

• FDA approval · 2013-02-25
  FDA Approved: ALENDRONATE SODIUM — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved Hikma Pharmaceuticals USA Inc.'s generic alendronate sodium tablets under an original ANDA (ANDA 090520). The approval covers o…

• FDA approval · 2013-02-15
  FDA Approved: TERIPARATIDE — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for Teriparatide submitted by Prasco Laboratories, signaling regulatory approval related to a generi…

• FDA approval · 2012-08-13
  FDA Approved: ATELVIA — Supplemental Application (Allergan, Inc.)

  FDA approved a supplemental application for ATELVIA (risedronate sodium) from Allergan.

• FDA approval · 2012-06-25
  FDA Approved: ALENDRONATE SODIUM — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for alendronate sodium supplied by Aurobindo Pharma Limited under ANDA090124.

• FDA approval · 2012-05-22
  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, indicating updated labeling or a…