Osteoporosis

• FDA approval · 2015-11-30
  FDA Approved: FOSAMAX PLUS D — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for FOSAMAX PLUS D (alendronate with cholecalciferol) submitted by Organon LLC.

• FDA approval · 2015-11-30
  FDA Approved: FOSAMAX — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for FOSAMAX (alendronate sodium) from Organon LLC.

• FDA approval · 2015-11-30
  FDA Approved: RISEDRONATE SODIUM — Original Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved Sun Pharmaceutical Industries' risendronate sodium generic product under an Original Application (ANDA). Risendronate sodiu…

• FDA approval · 2015-11-23
  FDA Approved: TERIPARATIDE — Supplemental Application (Prasco Laboratories)

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

• FDA approval · 2015-11-19
  FDA Approved: ZOLEDRONIC ACID — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for Zoledronic Acid from Hikma Pharmaceuticals USA Inc., resulting in a supplemental approval fo…

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• FDA approval · 2015-10-31
  FDA Approved: CALCITONIN SALMON — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application from Apotex Corp. for calcitonin salmon (generic), resulting in an updated approval under the ANDA p…

• FDA approval · 2015-10-19
  FDA Approved: ZOLEDRONIC ACID — Supplemental Application (BPI Labs LLC)

  FDA approves a supplemental application for zoledronic acid from BPI Labs LLC under ANDA 202930. This action supports continued availability…

• FDA approval · 2015-10-16
  FDA Approved: IBANDRONATE SODIUM — Original Application (Apotex Corp.)

  FDA approved the original application for ibandronate sodium (generic) by Apotex Corp., enabling generic access to the osteoporosis treatmen…

• FDA approval · 2015-09-23
  FDA Approved: ALENDRONATE SODIUM — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for alendronate sodium by Hikma Pharmaceuticals USA Inc., adding regulatory approval status for this…

• FDA approval · 2015-09-21
  FDA Approved: ZOLEDRONIC ACID — Supplemental Application (Dr. Reddy's Laboratories Limited)

  The FDA approved a supplemental application for zoledronic acid from Dr. Reddy's Laboratories Limited.

• FDA approval · 2015-09-02
  FDA Approved: IBANDRONATE SODIUM — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for ibandronate sodium submitted by Sun Pharmaceutical Industries, Inc.

• FDA approval · 2015-09-02
  FDA Approved: IBANDRONATE SODIUM — Supplemental Application (Mylan Institutional LLC)

  FDA approved a supplemental application for ibandronate sodium submitted by Mylan Institutional LLC (ANDA 202671), indicating approved chang…

• FDA approval · 2015-08-28
  FDA Approved: RALOXIFENE HYDROCHLORIDE — Original Application (Aurobindo Pharma Limited)

  The FDA approved Aurobindo Pharma Limited's original application for raloxifene hydrochloride as a generic medication for postmenopausal ost…

• FDA approval · 2015-08-19
  FDA Approved: IBANDRONATE SODIUM — Original Application (Eugia US LLC)

  FDA approved Eugia US LLC's original Abbreviated New Drug Application for ibandronate sodium, a generic version of a drug used to treat oste…

• FDA approval · 2015-07-16
  FDA Approved: ALENDRONATE SODIUM — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved a supplemental application for ALENDRONATE SODIUM submitted by Amneal Pharmaceuticals of New York LLC (ANDA075710).

• FDA approval · 2015-07-15
  FDA Approved: IBANDRONATE SODIUM — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approves a supplemental application for ibandronate sodium from Dr. Reddy's Laboratories Limited. The action confirms approval of this g…

• FDA approval · 2015-07-15
  FDA Approved: IBANDRONATE SODIUM — Supplemental Application (Bionpharma Inc.)

  FDA approves a supplemental application for ibandronate sodium from Bionpharma Inc.

• FDA approval · 2015-07-10
  FDA Approved: FOSAMAX PLUS D — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for Fosamax Plus D (alendronate sodium and cholecalciferol) from Organon LLC. The approval updates t…

• FDA approval · 2015-05-27
  FDA Approved: ZOLEDRONIC ACID — Supplemental Application (BPI Labs LLC)

  FDA approved a supplemental application for zoledronic acid from BPI Labs LLC under an ANDA.

• FDA approval · 2015-05-21
  FDA Approved: PROLIA — Supplemental Application (Amgen, Inc)

  The FDA approved Amgen's supplemental application for Prolia (denosumab).

• FDA approval · 2015-04-09
  FDA Approved: ZOLEDRONIC ACID — Supplemental Application (Dr.Reddy's Laboratories Ltd)

  FDA approved a supplemental application for zoledronic acid from Dr. Reddy's Laboratories Ltd (ANDA 091363), granting regulatory approval of…

• FDA approval · 2015-04-08
  FDA Approved: ACTONEL — Supplemental Application (Allergan, Inc.)

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

• FDA approval · 2015-04-08
  FDA Approved: PROLIA — Supplemental Application (Amgen, Inc)

  FDA approved a supplemental application for PROLIA (denosumab) submitted by Amgen, Inc.

• FDA approval · 2015-04-08
  FDA Approved: FOSAMAX — Supplemental Application (Organon LLC)

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

• FDA approval · 2015-04-08
  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.