Postmenopausal Osteoporosis
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Sign up freeTop drugs studied for this disease
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FDA label_change · 2013-04-24FDA Approved: VIVELLE-DOT — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application for VIVELLE-DOT (estradiol) from Sandoz Inc, resulting in updated labeling.
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FDA approval · 2013-04-19FDA Approved: ACTONEL — Supplemental Application (Allergan, Inc.)
FDA approved Allergan's supplemental application for Actonel (risendronate sodium).
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FDA approval · 2013-04-19FDA Approved: FOSAMAX PLUS D — Supplemental Application (Organon LLC)
The FDA approved a supplemental NDA for Fosamax Plus D (alendronate sodium and cholecalciferol) from Organon LLC. The action approves a supp…
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FDA approval · 2013-04-19FDA Approved: ATELVIA — Supplemental Application (Allergan, Inc.)
FDA approved a supplemental application for Atelvia (risendronate sodium) submitted by Allergan, Inc.
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FDA approval · 2013-04-19FDA Approved: BINOSTO — Supplemental Application (Radius Health, Inc.)
The FDA has approved a supplemental application for BINOSTO (alendronate sodium) from Radius Health, Inc. The approval updates the labeling …
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CLINICAL_TRIALS trial_result · 2013-04-18Clinical Trial Update: Molecular Mechanism of POP Kidney Yin Deficiency Syndrome From the Interventional Effects of CLCF1 [Phase 2]
Phase 2 clinical trial update exploring the interventional effects of CLCF1 on Postmenopausal Osteoporosis within the context of Kidney Yin …
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FDA approval · 2013-04-17FDA Approved: BINOSTO — Supplemental Application (Radius Health, Inc.)
The FDA approved a supplemental application for BINOSTO (alendronate sodium) to expand its label for the treatment of osteoporosis.
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CLINICAL_TRIALS trial_result · 2013-04-17Clinical Trial Update: Safety, Pharmacokinetics, and Efficacy of 100, 150, and 200 mg Risedronate Administered to Women With Low BMD [Phase 2]
Phase 2 study evaluating safety, pharmacokinetics, and efficacy of 100, 150, and 200 mg risedronate in postmenopausal women with low bone mi…
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FDA approval · 2013-03-13FDA Approved: TERIPARATIDE — Supplemental Application (Prasco Laboratories)
The FDA approved a supplemental application for Teriparatide submitted by Prasco Laboratories. The approval updates the drug’s labeling and/…
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FDA approval · 2013-03-08FDA Approved: IBANDRONATE SODIUM — Supplemental Application (Dr. Reddy's Laboratories Limited)
FDA approved a supplemental application for ibandronate sodium submitted by Dr. Reddy's Laboratories Limited.
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FDA approval · 2013-02-25FDA Approved: ALENDRONATE SODIUM — Original Application (Hikma Pharmaceuticals USA Inc.)
FDA approved Hikma Pharmaceuticals USA Inc.'s generic alendronate sodium tablets under an original ANDA (ANDA 090520). The approval covers o…
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CLINICAL_TRIALS trial_result · 2013-02-21Clinical Trial Update: Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of PTH Analog Tablets in Postmenopausal Women [Phase 2]
Phase 2 study evaluating pharmacodynamics, pharmacokinetics, safety and tolerability of PTH analog tablets in postmenopausal women with oste…
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FDA approval · 2013-02-15FDA Approved: TERIPARATIDE — Supplemental Application (Prasco Laboratories)
FDA approved a supplemental application for Teriparatide submitted by Prasco Laboratories, signaling regulatory approval related to a generi…
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CLINICAL_TRIALS trial_result · 2013-01-17Clinical Trial Update: Comparative Effect of Zoledronic Acid Versus Denosumab on Serum Sclerostin of Postmenopausal Women With Low Bone Mass [NA]
A completed head-to-head trial compares the effects of zoledronic acid versus denosumab on serum sclerostin levels in postmenopausal women w…
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CLINICAL_TRIALS trial_result · 2012-11-29Clinical Trial Update: A Study to Evaluate the Safety and Efficacy of Denosumab and Ibandronate in Postmenopausal Women Sub-Optimally Treated With Daily or Weekly Bisphosphonates [Phase 3]
Phase 3 trial evaluating safety and efficacy of combining denosumab with ibandronate in postmenopausal osteoporosis patients sub-optimally t…
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CLINICAL_TRIALS trial_result · 2012-11-16Clinical Trial Update: MK-5442 in the Treatment of Osteoporosis in Postmenopausal Women Previously Treated With an Oral Bisphosphonate (MK-5442-012) [Phase 2]
This Phase 2 clinical trial update reports results for MK-5442 in treating osteoporosis in postmenopausal women previously treated with an o…
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CLINICAL_TRIALS trial_result · 2012-10-23Clinical Trial Update: A Multiple-Dose Study to Evaluate Skin Irritation and Sensitization of Teriparatide Administered Transdermally in Healthy Postmenopausal Women [Phase 1]
Phase 1 multiple-dose study evaluating skin irritation and sensitization from transdermal teriparatide in healthy postmenopausal women; resu…
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CLINICAL_TRIALS trial_result · 2012-09-03Clinical Trial Update: Clinical Study of Raloxifene and Strontium Ranelate in Postmenopausal Osteoporosis [Phase 4]
Phase 4 clinical study evaluating the combination of raloxifene and strontium ranelate in postmenopausal osteoporosis has completed.
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FDA approval · 2012-08-13FDA Approved: ATELVIA — Supplemental Application (Allergan, Inc.)
FDA approved a supplemental application for ATELVIA (risedronate sodium) from Allergan.
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FDA approval · 2012-06-25FDA Approved: ALENDRONATE SODIUM — Supplemental Application (Aurobindo Pharma Limited)
The FDA approved a supplemental application for alendronate sodium supplied by Aurobindo Pharma Limited under ANDA090124.
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EMA withdrawal · 2012-06-21EMA Lapsed: Fablyn (Lasofoxifene tartrate) — Dr. Friedrich Eberth Arzneimittel GmbH
EMA indicates the marketing authorization for Fablyn (lasofoxifene tartrate) has lapsed, primarily in the osteoporosis/postmenopausal settin…
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FDA approval · 2012-05-22FDA Approved: ALENDRONATE SODIUM — Supplemental Application (Amneal Pharmaceuticals of New York LLC)
FDA approved a supplemental application for alendronate sodium from Amneal Pharmaceuticals of New York LLC, indicating updated labeling or a…
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FDA approval · 2012-05-16FDA Approved: ALENDRONATE — Supplemental Application (Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd.)
FDA approved a supplemental application for ALENDRONATE SODIUM tablets from Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd., enabling a …
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FDA approval · 2012-04-30FDA Approved: IBANDRONATE SODIUM — Original Application (Dr. Reddy's Laboratories Limited)
FDA approved Dr. Reddy's Laboratories' ibandronate sodium as an original ANDA, enabling a generic product for osteoporosis in postmenopausal…
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FDA approval · 2012-04-27FDA Approved: PROLIA — Supplemental Application (Amgen, Inc)
The FDA approved a supplemental application for PROLIA (denosumab) filed by Amgen.