Osteoporosis

• FDA label_change · 2023-10-27
  FDA Approved: IBANDRONATE SODIUM — Supplemental Application (Apotex Corp)

  The FDA approved a supplemental application for ibandronate sodium from Apotex Corp, typically indicating a labeling modification under the …

• FDA label_change · 2023-04-28
  FDA Approved: RISEDRONATE SODIUM — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved Sun Pharmaceutical Industries, Inc.'s supplemental application for risedronate sodium, resulting in updated labeling. This …

• FDA label_change · 2016-01-25
  FDA Approved: EVISTA — Supplemental Application (Eli Lilly and Company)

  FDA approved a supplemental application for Evista (raloxifene hydrochloride) filed by Eli Lilly, resulting in changes to the product labeli…

• FDA label_change · 2015-10-23
  FDA Approved: RISEDRONATE SODIUM — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for Risendronate Sodium from Sun Pharmaceutical Industries to update labeling for the generic os…

• FDA label_change · 2015-10-22
  FDA Approved: ACTONEL — Supplemental Application (Allergan, Inc.)

  FDA overview documenting Allergan's supplemental application for Actonel (risendronate sodium) to update labeling.

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• FDA label_change · 2015-10-08
  FDA Approved: ZOLEDRONIC ACID — Supplemental Application (Sagent Pharmaceuticals)

  FDA supplemental application for Zoledronic Acid submitted by Sagent Pharmaceuticals to modify the drug's labeling.

• FDA label_change · 2015-02-26
  FDA Approved: BINOSTO — Supplemental Application (Radius Health, Inc.)

  The FDA approved a supplemental application for Binosto (alendronate sodium) filed by Radius Health, Inc., to update the drug's labeling.

• FDA label_change · 2014-11-05
  FDA Approved: RISEDRONATE SODIUM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for risendronate sodium from Teva, indicating labeling changes to the generic product.

• FDA label_change · 2014-06-16
  FDA Approved: PROLIA — Supplemental Application (Amgen, Inc)

  FDA approved a supplemental labeling application for PROLIA (denosumab) submitted by Amgen to update the product labeling.

• FDA label_change · 2014-05-13
  FDA Approved: RECLAST — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for Reclast (zoledronic acid) filed by Sandoz Inc, typically to update the product labeling.

• FDA label_change · 2013-08-02
  FDA Approved: BINOSTO — Supplemental Application (Radius Health, Inc.)

  The FDA approved a supplemental application for BINOSTO (alendronate sodium) from Radius Health, updating the product labeling.

• FDA label_change · 2012-06-07
  FDA Approved: PROLIA — Supplemental Application (Amgen, Inc)

  FDA approves Amgen's supplemental application for PROLIA (denosumab) to modify the product labeling. The action pertains to updating the lab…

• FDA label_change · 2012-05-17
  FDA Approved: ALENDRONATE SODIUM — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for alendronate sodium by Aurobindo Pharma Limited, indicating a modification to an already approved…

• EMA label_change · 2012-03-16
  European Medicines Agency confirms positive benefit-risk balance of Protelos / Osseor, but recommends new contraindications and revised warnings

  The EMA confirms a positive overall benefit-risk for Protelos/Osseor but recommends new contraindications and revised warnings.

• FDA label_change · 2011-01-25
  FDA Approved: ACTONEL — Supplemental Application (Allergan, Inc.)

  FDA approved a supplemental application for Actonel (risendronate sodium) filed by Allergan, Inc., to update the labeling related to its app…

• FDA label_change · 2009-10-30
  FDA Approved: MIACALCIN — Supplemental Application (Mylan Institutional LLC)

  FDA's page describes a supplemental application for Miacalcin (calcitonin salmon) submitted by Mylan Institutional LLC. The document signals…

• FDA label_change · 2007-07-24
  FDA Approved: ACTONEL — Supplemental Application (Allergan, Inc.)

  The FDA approved a supplemental application for Actonel (risendronate sodium) from Allergan, Inc., resulting in changes to the product label…