Osteoporosis

• FDA approval · 2013-03-29
  FDA Approved: ALENDRONATE — Supplemental Application (Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd.)

  FDA approved a supplemental application for alendronate sodium tablets from Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd.

• FDA approval · 2013-03-29
  FDA Approved: ZOLEDRONIC ACID — Original Application (Dr.Reddy's Laboratories Ltd)

  FDA approved the original application for Zoledronic acid (generic) from Dr. Reddy's Laboratories Ltd. This approval confirms a generic vers…

• 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 · 2013-03-04
  FDA Approved: ZOLEDRONIC ACID — Original Application (Mylan Institutional LLC)

  FDA approved an original application for a zoledronic acid generic product manufactured by Mylan Institutional LLC.

• FDA approval · 2013-03-04
  FDA Approved: ZOLEDRONIC ACID — Original Application (Dr. Reddy's Laboratories Limited)

  FDA approved Dr. Reddy's Laboratories Limited's zoledronic acid under an original application, enabling a generic version of the drug.

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• FDA approval · 2013-02-19
  FDA Approved: MIACALCIN — Supplemental Application (Mylan Institutional LLC)

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

• 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 · 2013-02-05
  FDA Approved: ALENDRONATE SODIUM — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for a generic alendronate sodium product from Aurobindo Pharma Limited (ANDA 090124). The approval a…

• FDA approval · 2012-09-20
  FDA Approved: PROLIA — Supplemental Application (Amgen, Inc)

  The FDA approved a supplemental application for PROLIA (denosumab) submitted by Amgen, Inc. This approval updates PROLIA's labeling or indic…

• FDA approval · 2012-09-14
  FDA Approved: PROLIA — Supplemental Application (Amgen, Inc)

  The FDA approved a supplemental application for PROLIA (denosumab) submitted by Amgen, Inc. The action updates labeling for the drug.

• 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 · 2012-07-12
  FDA Approved: CALCITONIN SALMON — Supplemental Application (Endo USA, Inc.)

  FDA approved a supplemental application for Calcitonin Salmon from Endo USA, Inc.

• 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…

• FDA approval · 2012-05-16
  FDA Approved: ALENDRONATE — Supplemental Application (Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd.)

  FDA approved a supplemental application for ALENDRONATE SODIUM tablets from Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd., enabling a …

• FDA approval · 2012-04-27
  FDA Approved: PROLIA — Supplemental Application (Amgen, Inc)

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

• FDA approval · 2012-04-25
  FDA Approved: CALCITONIN SALMON — Supplemental Application (Apotex Corp.)

  The FDA approved a supplemental application for Calcitonin Salmon from Apotex Corp., updating the approved product's regulatory status.

• FDA approval · 2012-03-19
  FDA Approved: IBANDRONATE SODIUM — Original Application (Apotex Corp)

  FDA approved the original application for ibandronate sodium by Apotex Corp, enabling a generic version of the osteoporosis treatment.

• FDA approval · 2012-03-19
  FDA Approved: IBANDRONATE SODIUM — Original Application (Bionpharma Inc.)

  FDA approved the original generic application for ibandronate sodium by Bionpharma Inc., enabling a generic version of the osteoporosis trea…

• FDA approval · 2012-03-13
  FDA Approved: TERIPARATIDE — Supplemental Application (Prasco Laboratories)

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

• FDA approval · 2012-03-12
  FDA Approved: BINOSTO — Original Application (Radius Health, Inc.)

  FDA approved Radius Health's BINOSTO (alendronate sodium) under an Original Application, granting regulatory approval for this product.

• FDA approval · 2012-02-06
  FDA Approved: FOSAMAX — Supplemental Application (Organon LLC)

  The FDA approved a supplemental application for Fosamax (alendronate sodium) from Organon LLC, updating the drug's labeling and/or approved …

• FDA approval · 2011-08-31
  FDA Approved: RECLAST — Supplemental Application (Sandoz Inc)

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

• FDA approval · 2011-08-22
  FDA Approved: ACTONEL — Supplemental Application (Allergan, Inc.)

  FDA approved a supplemental application for Actonel (risedronate sodium) by Allergan, Inc.

• FDA approval · 2011-08-22
  FDA Approved: ATELVIA — Supplemental Application (Allergan, Inc.)

  FDA approved Allergan's supplemental application for Atelvia (risendronate sodium), resulting in an approved label-related update for the pr…