Osteoporosis

• EMA approval · 2021-09-27
  EMA Authorised: Raloxifene Teva (raloxifene hydrochloride) — Teva B.V.

  European Medicines Agency has authorised Raloxifene Teva (raloxifene hydrochloride) for osteoporosis in postmenopausal women.

• FDA approval · 2021-09-07
  FDA Approved: TERIPARATIDE — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application for teriparatide submitted by Prasco Laboratories. This action relates to a supplemental approva…

• FDA approval · 2021-05-12
  FDA Approved: PROLIA — Supplemental Application (Amgen, Inc)

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

• FDA approval · 2020-11-16
  FDA Approved: TERIPARATIDE — Supplemental Application (Prasco Laboratories)

  FDA approved a supplemental application for teriparatide submitted by Prasco Laboratories, expanding or updating the drug's regulatory statu…

• FDA approval · 2020-10-23
  FDA Approved: TYMLOS — Supplemental Application (Radius Health, Inc.)

  FDA approved a supplemental application for TYMLOS (abaloparatide) from Radius Health, Inc. The approval updates the product labeling.

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• FDA approval · 2020-10-20
  FDA Approved: ZOLEDRONIC ACID — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Zoledronic acid from Hikma Pharmaceuticals USA Inc., indicating regulatory approval for the spon…

• FDA approval · 2020-10-19
  FDA Approved: ZOLEDRONIC ACID — Supplemental Application (Mylan Institutional LLC)

  FDA approved a supplemental application for zoledronic acid from Mylan Institutional LLC under an abbreviated new drug application (ANDA), e…

• FDA approval · 2020-08-26
  FDA Approved: CALCITONIN SALMON — Supplemental Application (Endo USA, Inc.)

  The FDA approved a supplemental application for Calcitonin Salmon (Endo USA, Inc.), resulting in updated labeling for the product.

• FDA approval · 2020-08-18
  FDA Approved: ATELVIA — Supplemental Application (Allergan, Inc.)

  FDA approved a supplemental application for Atelvia (risendronate sodium) from Allergan, Inc., signaling an update to the product's labeling…

• FDA approval · 2020-06-19
  FDA Approved: IBANDRONATE SODIUM — Supplemental Application (Dr. Reddy's Laboratories Limited)

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

• FDA approval · 2020-06-09
  FDA Approved: PROLIA — Supplemental Application (Amgen, Inc)

  The FDA has approved a supplemental application for PROLIA (denosumab) by Amgen, Inc., amending its labeling/indications.

• FDA approval · 2020-04-29
  FDA Approved: RECLAST — Supplemental Application (Sandoz Inc)

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

• FDA approval · 2020-04-06
  FDA Approved: TERIPARATIDE — Supplemental Application (Prasco Laboratories)

  The FDA approved a supplemental application for teriparatide submitted by Prasco Laboratories under NDA 021318.

• FDA approval · 2020-02-21
  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, authorizing a generic product through…

• FDA approval · 2020-02-21
  FDA Approved: ZOLEDRONIC ACID — Supplemental Application (BluePoint Laboratories)

  FDA approved a supplemental application for zoledronic acid submitted by BluePoint Laboratories (ANDA205279).

• FDA approval · 2019-12-20
  FDA Approved: EVENITY — Supplemental Application (Amgen, Inc)

  FDA approved a supplemental application for Evenity (romosozumab-aqqg) from Amgen, reflecting regulatory approval based on the supplemental …

• FDA approval · 2019-12-17
  FDA Approved: IBANDRONATE SODIUM — Supplemental Application (Apotex Corp.)

  The FDA approved a supplemental application for Apotex Corp. to market a generic ibandronate sodium product.

• FDA approval · 2019-10-04
  FDA Approved: TERIPARATIDE — Original Application (Alvogen, Inc.)

  The FDA approved the original application for teriparatide from Alvogen, enabling its use for osteoporosis treatment.

• FDA approval · 2019-10-03
  FDA Approved: TERIPARATIDE — Supplemental Application (Prasco Laboratories)

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

• FDA approval · 2019-08-23
  FDA Approved: RALOXIFENE HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for a generic raloxifene hydrochloride product from Aurobindo Pharma Limited.

• FDA approval · 2019-08-19
  FDA Approved: ALENDRONATE SODIUM — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for alendronate sodium by Hikma Pharmaceuticals USA Inc.

• FDA approval · 2019-08-16
  FDA Approved: FOSAMAX PLUS D — Supplemental Application (Organon LLC)

  The FDA approved a supplemental application for Fosamax Plus D (alendronate sodium and cholecaliferol) from Organon LLC. This action updates…

• FDA approval · 2019-07-26
  FDA Approved: PROLIA — Supplemental Application (Amgen, Inc)

  FDA approved a supplemental application for PROLIA (denosumab) filed by Amgen, expanding the regulatory status of the product.

• FDA approval · 2019-07-09
  FDA Approved: RISEDRONATE SODIUM — Original Application (Sun Pharmaceutical Industires Inc.)

  FDA approved Sun Pharmaceutical's risendronate sodium as an original application for a generic product, with indications for osteoporosis-re…

• FDA approval · 2019-02-15
  FDA Approved: RISEDRONATE SODIUM — Original Application (Hangzhou Minsheng Binjiang Pharmaceutical CO., Ltd)

  FDA approved the generic drug risedronate sodium under an Original Application, expanding access to this bisphosphonate for osteoporosis- an…