Postmenopausal Osteoporosis

• CLINICAL_TRIALS trial_result · 2024-07-16
  Clinical Trial Update: How Vertebral Fractures Effect Balance In Postmenopausal Women

  This clinical trial update notes the completion of a study assessing how vertebral fractures affect balance in postmenopausal women with ost…

• FDA approval · 2024-07-11
  FDA Approved: IBANDRONATE SODIUM — Supplemental Application (Apotex Corp.)

  The FDA approved a supplemental application for ibandronate sodium from Apotex Corp. under ANDA204222. This represents an update to the prev…

• CLINICAL_TRIALS research · 2024-06-26
  Clinical Trial Update: Treatment Exercises With Core Stability and Dynamic Resistance Exercise for Postmenopausal Women With Osteoporosis [NA]

  A completed clinical trial studying exercise-based therapy (core stability and dynamic resistance training) for postmenopausal osteoporosis.

• FDA approval · 2024-06-13
  FDA Approved: ESTRADIOL — Supplemental Application (NorthStar Rx LLC)

  FDA approved a supplemental application for Estradiol (ESTRADIOL) from NorthStar Rx LLC under the ANDA program.

• CLINICAL_TRIALS research · 2024-05-16
  Clinical Trial Update: Eldecalcitol and Calcitriol in Postmenopausal Women With Low Bone Mineral Density or Mild Osteoporosis [Phase 4]

  A Phase 4 trial evaluating eldecalcitol and calcitriol in postmenopausal women with low bone mineral density or mild osteoporosis is current…

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• CLINICAL_TRIALS trial_result · 2024-05-14
  Clinical Trial Update: Efficacy of Zoledronic Acid to Prevent Bone Loss Following Denosumab Discontinuation

  A clinical trial update evaluating whether zoledronic acid prevents bone loss after discontinuation of denosumab. The sponsor is the Univers…

• CLINICAL_TRIALS trial_result · 2024-05-09
  Clinical Trial Update: Coral Calcium's Effect on Bone Density in Postmenopausal Women With and Without Ibandronate [Phase 2]

  A Phase 2 clinical trial evaluating coral calcium's effect on bone density in postmenopausal women, with and without ibandronate, has comple…

• CLINICAL_TRIALS research · 2024-04-26
  Clinical Trial Update: Comparative Efficacy, Safety, PK, and Immunogenicity Study [Phase 3]

  Phase 3 clinical trial update evaluating comparative efficacy, safety, pharmacokinetics, and immunogenicity in postmenopausal osteoporosis; …

• FDA approval · 2024-04-22
  FDA Approved: ESTRADIOL — Original Application (Solaris Pharma Corporation)

  FDA approves Solaris Pharma Corporation's Estradiol as an original application (generic) product for estrogen replacement therapy.

• CLINICAL_TRIALS trial_result · 2024-04-18
  Clinical Trial Update: A Study to Test if TVB-009P is Effective in Relieving Postmenopausal Osteoporosis [Phase 3]

  Phase 3 trial evaluating TVB-009P for relief of postmenopausal osteoporosis has completed; results posted in 2024.

• CLINICAL_TRIALS trial_result · 2024-04-17
  Clinical Trial Update: Effect of Raloxifene Plus Cholecalciferol and Cholecalciferol Alone on the Bone Mineral Density in Postmenopausal Women With Osteopenia [Phase 4]

  Phase 4 clinical trial evaluating the effects of raloxifene with cholecalciferol versus cholecalciferol alone on bone mineral density in pos…

• EMA approval · 2024-04-12
  EMA Authorised: Eladynos (abaloparatide) — Theramex Ireland Limited

  EMA has authorised Eladynos (abaloparatide) for osteoporosis, including postmenopausal osteoporosis, with Theramex Ireland Limited as the MA…

• FDA approval · 2024-04-11
  FDA Approved: CALCITONIN SALMON — Original Application (Dr. Reddy's Laboratories, Inc.)

  FDA approved the original application for Calcitonin Salmon from Dr. Reddy's Laboratories, Inc., enabling the generic to enter the market.

• FDA approval · 2024-04-09
  FDA Approved: PROLIA — Supplemental Application (Amgen, Inc)

  The FDA approved Amgen's supplemental application for Prolia (denosumab). This action likely updates the drug's labeling.

• FDA approval · 2024-03-05
  FDA Approved: PROLIA — Supplemental Application (Amgen, Inc)

  FDA approved a supplemental application for PROLIA (denosumab) submitted by Amgen. The action indicates an expanded or updated indication fo…

• FDA approval · 2024-03-04
  FDA Approved: DUAVEE — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)

  FDA approved a supplemental application for Duavee (conjugated estrogens/bazedoxifene) submitted by Wyeth Pharmaceuticals LLC (a subsidiary …

• CLINICAL_TRIALS research · 2024-02-20
  Clinical Trial Update: Effect of Epidural Steroid Injection on Bone Mineral Density in Postmenopausal Women [Phase 4]

  Phase 4 clinical trial evaluating the impact of epidural steroid injections on bone turnover markers and bone mineral density in postmenopau…

• FDA approval · 2024-02-15
  FDA Approved: ELESTRIN — Supplemental Application (Viatris Specialty LLC)

  FDA approved a supplemental application for ELESTRIN (estradiol) from Viatris Specialty LLC. The approval updates the labeling to incorporat…

• FDA label_change · 2024-02-15
  FDA Approved: VIVELLE-DOT — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for VIVELLE-DOT (estradiol) filed by Sandoz, resulting in labeling changes.

• FDA approval · 2023-12-21
  FDA Approved: TYMLOS — Supplemental Application (Radius Health, Inc.)

  FDA approved a supplemental application for TYMLOS (abaloparatide) submitted by Radius Health, Inc., updating the labeling for osteoporosis …

• FDA approval · 2023-12-18
  FDA Approved: RISEDRONATE SODIUM — Supplemental Application (Sun Pharmaceutical Industires Inc.)

  The FDA approved a supplemental application for Risedronate Sodium submitted by Sun Pharmaceutical Industries Inc.

• CLINICAL_TRIALS trial_result · 2023-11-22
  Clinical Trial Update: Study to Evaluate the Pharmacokinetics (PK), Pharmacodynamics (PD), and Usability of Abaloparatide-solid Microstructured Transdermal System (sMTS) in Postmenopausal Women With Low Bone Mineral Density (BMD) [Phase 1]

  Phase 1 study evaluating pharmacokinetics, pharmacodynamics, and usability of abaloparatide sMTS in postmenopausal women with low bone miner…

• FDA approval · 2023-11-20
  FDA Approved: LYLLANA — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for LYLLANA (estradiol) from Amneal Pharmaceuticals LLC (ANDA 211396).

• FDA approval · 2023-11-16
  FDA Approved: TERIPARATIDE — Supplemental Application (Alvogen, Inc.)

  The FDA approved a supplemental application for teriparatide submitted by Alvogen, Inc.

• FDA approval · 2023-11-14
  FDA Approved: ESTRADIOL — Original Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved an Estradiol generic product from Padagis Israel Pharmaceuticals Ltd under an Original Application, enabling its use for estrog…