Postmenopausal Osteoporosis
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Sign up freeTop drugs studied for this disease
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FDA approval · 2015-05-29FDA Approved: YUVAFEM — Original Application (Amneal Pharmaceuticals LLC)
The FDA approved Amneal's YUVAFEM, a generic estradiol product, under an Original Application (ANDA205256).
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CLINICAL_TRIALS research · 2015-05-28Clinical Trial Update: Optimizing Body Composition & Health After Breast Cancer [NA]
A completed clinical trial studying body composition and health after breast cancer treatment. The conditions include postmenopausal osteopo…
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CLINICAL_TRIALS trial_result · 2015-04-17Clinical Trial Update: Julina Post-marketing Surveillance for Postmenopausal Osteoporosis in Japan
A completed post-marketing surveillance study in Japan evaluating Julina for postmenopausal osteoporosis.
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CLINICAL_TRIALS trial_result · 2015-04-15Clinical Trial Update: Soluble Corn Fiber Effect on Bone Resorption in Post Menopausal Women [NA]
A completed Purdue University clinical trial investigated whether soluble corn fiber influences bone resorption in postmenopausal women with…
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CLINICAL_TRIALS trial_result · 2015-04-09Clinical Trial Update: Radius Loading in Primary Hyperparathyroidism [NA]
A Columbia University–sponsored clinical trial evaluating radius loading in primary hyperparathyroidism has completed.
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FDA approval · 2015-04-08FDA Approved: ACTONEL — Supplemental Application (Allergan, Inc.)
FDA approved a supplemental application for Actonel (risendronate sodium) submitted by Allergan, Inc.
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FDA approval · 2015-04-08FDA Approved: PROLIA — Supplemental Application (Amgen, Inc)
FDA approved a supplemental application for PROLIA (denosumab) submitted by Amgen, Inc.
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FDA approval · 2015-04-08FDA Approved: BINOSTO — Supplemental Application (Radius Health, Inc.)
FDA approved Radius Health's supplemental application for Binosto (alendronate sodium).
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FDA approval · 2015-04-08FDA 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.
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FDA approval · 2015-03-26FDA Approved: ATELVIA — Supplemental Application (Allergan, Inc.)
FDA approved a supplemental application for Atelvia (risendronate sodium) filed by Allergan, expanding/ updating the product's labeling thro…
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FDA approval · 2015-01-26FDA Approved: ANGELIQ — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)
FDA approved ANGELIQ—Supplemental Application for the Bayer HealthCare Pharmaceuticals Inc. product. The approval concerns the drospirenone …
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FDA approval · 2014-12-05FDA Approved: PROLIA — Supplemental Application (Amgen, Inc)
FDA approved a supplemental application for PROLIA (denosumab) from Amgen, expanding its approved use.
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FDA label_change · 2014-12-02FDA Approved: ACTONEL — Supplemental Application (Allergan, Inc.)
FDA approved a supplemental application for ACTONEL (risendronate sodium) from Allergan, Inc., updating the product labeling.
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CLINICAL_TRIALS research · 2014-10-22Clinical Trial Update: Observational Study of iv Ibandronate in Women With Postmenopausal Osteoporosis
This document reports the completion of an observational study evaluating intravenous ibandronate in women with postmenopausal osteoporosis.
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FDA approval · 2014-09-24FDA Approved: RALOXIFENE HYDROCHLORIDE — Original Application (Cipla USA Inc.)
The FDA approved Cipla USA Inc.'s original generic application for raloxifene hydrochloride, enabling a generic version of the osteoporosis …
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FDA approval · 2014-09-12FDA Approved: TERIPARATIDE — Supplemental Application (Prasco Laboratories)
FDA approved a supplemental application for teriparatide submitted by Prasco Laboratories under NDA 021318.
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CLINICAL_TRIALS trial_result · 2014-09-09Clinical Trial Update: Epidemiology, Identification Rate and Treatment Penetration of Osteoporotic Vertebral Fractures in Switzerland
This clinical trial update reports on the epidemiology, identification rate, and treatment penetration of osteoporotic vertebral fractures i…
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FDA approval · 2014-09-02FDA Approved: IBANDRONATE SODIUM — Original Application (Mylan Institutional LLC)
FDA approved an Abbreviated New Drug Application for ibandronate sodium from Mylan Institutional LLC, granting a generic version of ibandron…
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CLINICAL_TRIALS trial_result · 2014-07-22Clinical Trial Update: A Study to Evaluate Alendronate Sodium /Vitamin D3 Combination Tablets(FOSAMAX PLUS) Versus Calcitriol in the Treatment of Osteoporosis in Postmenopausal Women in China (MK-0217A-264) [Phase 4]
This Phase 4 study evaluated alendronate sodium plus vitamin D3 (Fosamax Plus) versus calcitriol for osteoporosis in postmenopausal women in…
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EMA withdrawal · 2014-07-02EMA Withdrawn: Preotact (parathyroid hormone (rDNA)) — NPS Pharma Holdings Limited
EMA has withdrawn Preotact (parathyroid hormone rDNA) from the market.
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FDA approval · 2014-06-10FDA Approved: RISEDRONATE SODIUM — Original Application (Apotex Corp.)
FDA approved Apotex Corp.'s original ANDA for risedronate sodium, a generic version of Actonel. The approval covers indications for treating…
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FDA approval · 2014-06-04FDA Approved: PROLIA — Supplemental Application (Amgen, Inc)
The FDA approved a supplemental application for PROLIA (denosumab) submitted by Amgen, Inc. This action expands regulatory approval for the …
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CLINICAL_TRIALS research · 2014-05-20Clinical Trial Update: Longitudinal Study of Primary Osteoporosis in Shanghai Postmenopausal Women
This is a longitudinal clinical trial studying postmenopausal osteoporosis in Shanghai. The sponsor is Shanghai University of Traditional Ch…
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CLINICAL_TRIALS trial_result · 2014-04-28Clinical Trial Update: 3-Week Parathyroid Hormone-related Protein (PTHrP) Dose Escalation Study in Post-Menopausal Women [Phase 1]
This document reports a Phase 1, dose-escalation trial of parathyroid hormone-related protein (PTHrP) in postmenopausal women with osteoporo…
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FDA approval · 2014-04-11FDA Approved: CONJUGATED ESTROGENS — Supplemental Application (Prasco Laboratories)
FDA approved a supplemental application for conjugated estrogens (Estrogens, Conjugated) filed by Prasco Laboratories, representing a regula…