Postmenopausal Osteoporosis

• FDA approval · 2021-11-10
  FDA Approved: CALCITONIN SALMON — Original Application (Par Health USA, LLC)

  The FDA approved Par Health USA's generic Calcitonin Salmon under ANDA 209358.

• FDA approval · 2021-10-07
  FDA Approved: CLIMARA PRO — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Climara Pro (estradiol and levonorgestrel) submitted by Bayer, potentially updating labeling…

• 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 · 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…

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• 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.

• FDA approval · 2020-10-13
  FDA Approved: BINOSTO — Supplemental Application (Radius Health, Inc.)

  The FDA approved a supplemental application for BINOSTO (alendronate sodium) from Radius Health, Inc., supporting a label expansion/updated …

• FDA approval · 2020-08-18
  FDA Approved: RALOXIFENE HYDROCHLORIDE — Original Application (Modavar Pharmaceuticals LLC)

  FDA approved Modavar Pharmaceuticals' original application for raloxifene hydrochloride, enabling a generic version of the drug.

• FDA approval · 2020-08-06
  FDA Approved: RISEDRONATE SODIUM — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for Risendronate Sodium from Aurobindo Pharma Limited.

• 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 · 2020-06-08
  FDA Approved: BINOSTO — Supplemental Application (Radius Health, Inc.)

  FDA approves a supplemental application for BINOSTO (alendronate sodium) submitted by Radius Health, 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 · 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 · 2019-10-03
  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 (ScieGen Pharmaceuticals Inc)

  FDA approved a supplemental application for raloxifene hydrochloride submitted by ScieGen Pharmaceuticals Inc.

• FDA approval · 2019-08-23
  FDA Approved: RALOXIFENE HYDROCHLORIDE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark Pharmaceuticals' supplemental application for raloxifene hydrochloride (generic). The drug is indicated for postmenopa…

• 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 · 2019-04-09
  FDA Approved: EVENITY — Original Application (Amgen, Inc)

  FDA approved Amgen's romosozumab-aqqg (Evenity) for the treatment of osteoporosis in postmenopausal women at high risk for fracture. This en…

• 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…

• FDA approval · 2019-02-05
  FDA Approved: DOTTI — Original Application (Amneal Pharmaceuticals LLC)

  The FDA approved Amneal's original application for DOTTI, a generic estradiol product, expanding availability of estrogen replacement therap…

• FDA approval · 2019-01-04
  FDA Approved: ESTRADIOL — Supplemental Application (PURACAP LABORATORIES, LLC)

  The FDA granted approval for a supplemental application for Estradiol submitted by Puracap Laboratories, LLC, approving changes to an Estrad…

• FDA approval · 2018-08-27
  FDA Approved: ESTRADIOL — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Estradiol submitted by Mylan Pharmaceuticals Inc., granting regulatory approval for changes …

• FDA approval · 2018-06-20
  FDA Approved: TYMLOS — Supplemental Application (Radius Health, Inc.)

  The FDA approved a supplemental application for TYMLOS (abaloparatide) by Radius Health, Inc. This action reflects an approved supplemental …

• FDA approval · 2018-05-18
  FDA Approved: PROLIA — Supplemental Application (Amgen, Inc)

  FDA approved a supplemental application for Prolia (denosumab) submitted by Amgen, related to the drug's labeling/indication via a supplemen…

• FDA approval · 2018-04-06
  FDA Approved: IBANDRONATE SODIUM — Supplemental Application (Mylan Institutional LLC)

  FDA approved a supplemental application for ibandronate sodium from Mylan Institutional LLC, granting approval of a generic ibandronate prod…