Postmenopausal Osteoporosis
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Sign up freeTop drugs studied for this disease
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FDA approval · 2014-03-11FDA Approved: EVAMIST — Supplemental Application (Padagis US LLC)
FDA approved a supplemental application for EVAMIST (estradiol) by Padagis US LLC.
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FDA approval · 2014-03-05FDA Approved: TERIPARATIDE — Supplemental Application (Prasco Laboratories)
FDA approves a supplemental application for teriparatide submitted by Prasco Laboratories, establishing a generic version of the osteoporosi…
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FDA approval · 2014-03-04FDA Approved: RALOXIFENE HYDROCHLORIDE — Original Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved Teva's raloxifene hydrochloride generic as an Original Application (ANDA), enabling a generic product for postmenopausal os…
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FDA approval · 2014-02-27FDA Approved: ELESTRIN — Supplemental Application (Viatris Specialty LLC)
FDA approved a supplemental application for ELESTRIN (estradiol) submitted by Viatris Specialty LLC.
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FDA approval · 2014-02-14FDA Approved: IBANDRONATE SODIUM — Original Application (Sun Pharmaceutical Industries, Inc.)
FDA approved Sun Pharmaceutical's ibandronate sodium as an original-application generic product for postmenopausal osteoporosis.
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CLINICAL_TRIALS trial_result · 2014-02-10Clinical Trial Update: B-cryptoxanthin and Phytosterols on Bone Remodeling and Cardiovascular Risk Factors [Phase 1]
Phase 1 trial evaluating the effects of B-cryptoxanthin and phytosterols on bone remodeling and cardiovascular risk factors in postmenopausa…
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CLINICAL_TRIALS trial_result · 2014-01-22Clinical Trial Update: Clinical Comparison of Efficacy and Safety of Two Teriparatide Formulations: Osteofortil and Forteo [Phase 4]
A Phase 4 clinical trial compares two teriparatide formulations, Osteofortil and Forteo, for efficacy and safety in postmenopausal osteoporo…
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CLINICAL_TRIALS trial_result · 2013-12-25Clinical Trial Update: A Study in Indian Postmenopausal Women With Osteoporosis to Evaluate the Efficacy and Safety of Denosumab [Phase 3]
A Phase 3 trial in Indian postmenopausal women with osteoporosis completed and posted results evaluating the efficacy and safety of denosuma…
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FDA approval · 2013-12-23FDA Approved: FOSAMAX — Supplemental Application (Organon LLC)
The FDA approved a supplemental application for Fosamax (alendronate sodium) submitted by Organon LLC.
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FDA approval · 2013-12-23FDA Approved: BINOSTO — Supplemental Application (Radius Health, Inc.)
The FDA approved a supplemental application for BINOSTO (alendronate sodium) from Radius Health, Inc., resulting in changes to the product l…
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CLINICAL_TRIALS trial_result · 2013-12-16Clinical Trial Update: Patient- and Physician-Based Osteoporosis Education [Phase 1]
Phase 1 trial update evaluating patient- and physician-based education for osteoporosis; the study has completed.
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CLINICAL_TRIALS trial_result · 2013-11-19Clinical Trial Update: A Study Comparing Oral Calcitonin to Nasal Spray Calcitonin in Postmenopausal Osteoporotic Women [Phase 3]
Phase 3 trial comparing oral calcitonin to nasal spray calcitonin in postmenopausal osteoporosis completed; results were posted in 2013.
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CLINICAL_TRIALS safety_alert · 2013-11-19Clinical Trial Update: Angeliq Regulatory Post Marketing Surveillance
Bayer's Angeliq post-marketing surveillance update summarizes ongoing regulatory safety monitoring in postmenopausal women, including osteop…
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CLINICAL_TRIALS trial_result · 2013-11-07Clinical Trial Update: The Effects of Denosumab on the Pharmacokinetics (PK) of Midazolam [Phase 1]
Phase 1 trial investigating the effect of denosumab on the pharmacokinetics of midazolam in postmenopausal osteoporosis patients has complet…
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CLINICAL_TRIALS trial_result · 2013-10-29Clinical Trial Update: A Study in Korean Postmenopausal Women With Osteoporosis to Evaluate the Efficacy and Safety of Denosumab [Phase 3]
Phase 3 study in Korean postmenopausal women with osteoporosis evaluating denosumab completed, with results posted in 2013.
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CLINICAL_TRIALS trial_result · 2013-10-17Clinical Trial Update: A Transiliac Crest Bone Histology and Histomorphometry Study in Postmenopausal Women With Low Bone Mass or Osteoporosis Previously Treated With Denosumab [Phase 2]
Phase 2 clinical trial update describing a transiliac crest bone histology and histomorphometry study in postmenopausal women with low bone …
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FDA approval · 2013-10-03FDA Approved: DUAVEE — Original Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)
The FDA approved DUAVEE (conjugated estrogens/bazedoxifene) from Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc., as an original appl…
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CLINICAL_TRIALS trial_result · 2013-09-26Clinical Trial Update: Parathyroid Hormone (PTH) for Osteoporosis in Postmenopausal Women [Phase 2]
Phase 2 clinical trial update evaluating parathyroid hormone (PTH) for osteoporosis in postmenopausal women; the study has completed and res…
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FDA approval · 2013-08-30FDA Approved: TERIPARATIDE — Supplemental Application (Prasco Laboratories)
FDA has approved a supplemental application for teriparatide submitted by Prasco Laboratories, related to the NDA 021318 product.
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FDA approval · 2013-08-23FDA Approved: PROLIA — Supplemental Application (Amgen, Inc)
FDA approved a supplemental application for PROLIA (denosumab) submitted by Amgen, Inc., resulting in updated labeling for osteoporosis indi…
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FDA approval · 2013-08-02FDA Approved: TERIPARATIDE — Supplemental Application (Prasco Laboratories)
FDA approved a supplemental application for teriparatide submitted by Prasco Laboratories, authorizing its marketing.
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FDA label_change · 2013-08-02FDA Approved: BINOSTO — Supplemental Application (Radius Health, Inc.)
The FDA approved a supplemental application for BINOSTO (alendronate sodium) from Radius Health, updating the product labeling.
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CLINICAL_TRIALS trial_result · 2013-07-30Clinical Trial Update: An Open-label, Single-arm Extension Study to Evaluate the Long-term Safety of Denosumab Administration in Postmenopausal Women With Low Bone Mineral Density [Phase 3]
Open-label, single-arm Phase 3 extension study assessing the long-term safety of denosumab in postmenopausal women with low bone mineral den…
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CLINICAL_TRIALS trial_result · 2013-06-05Clinical Trial Update: Study of Bone Histomorphometry, Microarchitecture, and Matrix Structure in Patients Receiving Alendronate or Risedronate
A completed clinical trial evaluating bone histomorphometry, microarchitecture, and matrix structure in postmenopausal osteoporosis patients…
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EMA withdrawal · 2013-05-13EMA Withdrawn: Bondenza (previously Ibandronic Acid Roche) (ibandronic acid) — Roche Registration Ltd.
The EMA indicates that Bondenza (ibandronic acid) has been withdrawn from the market.