Glucocorticoid-induced Osteoporosis
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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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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 label_change · 2012-05-17FDA Approved: ALENDRONATE SODIUM — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for alendronate sodium by Aurobindo Pharma Limited, indicating a modification to an already approved…
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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 · 2012-03-13FDA Approved: TERIPARATIDE — Supplemental Application (Prasco Laboratories)
The FDA approved a supplemental application for teriparatide submitted by Prasco Laboratories.
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FDA approval · 2012-02-06FDA Approved: FOSAMAX — Supplemental Application (Organon LLC)
The FDA approved a supplemental application for Fosamax (alendronate sodium) from Organon LLC, updating the drug's labeling and/or approved …
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CLINICAL_TRIALS trial_result · 2011-11-08Clinical Trial Update: Comparison of the Effects of 2 Drugs on Lumbar Spine Volumetric BMD in Men With Glucocorticoid-Induced Osteoporosis [Phase 3]
Phase 3 trial comparing two drugs on lumbar spine volumetric bone mineral density in men with glucocorticoid-induced osteoporosis. The study…
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FDA approval · 2011-08-22FDA Approved: ACTONEL — Supplemental Application (Allergan, Inc.)
FDA approved a supplemental application for Actonel (risedronate sodium) by Allergan, Inc.
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FDA approval · 2011-08-10FDA Approved: TERIPARATIDE — Supplemental Application (Prasco Laboratories)
The FDA approved a supplemental application for teriparatide filed by Prasco Laboratories, expanding the regulatory status of the product un…
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FDA approval · 2011-07-07FDA Approved: ALENDRONATE SODIUM — Supplemental Application (EXELAN PHARMACEUTICALS INC.)
FDA approved a supplemental application for alendronate sodium submitted by Exelan Pharmaceuticals.
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FDA approval · 2011-04-06FDA Approved: ALENDRONATE SODIUM — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for ALENDRONATE SODIUM from Aurobindo Pharma Limited, indicating approval of a supplemental submissi…
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FDA approval · 2011-04-01FDA Approved: ALENDRONATE SODIUM — Supplemental Application (Amneal Pharmaceuticals of New York LLC)
FDA approved a supplemental application for alendronate sodium filed by Amneal Pharmaceuticals of New York LLC. This action updates the regu…
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FDA approval · 2011-02-15FDA Approved: ALENDRONATE SODIUM — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for Alendronate sodium filed by Aurobindo Pharma Limited.
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FDA label_change · 2011-01-25FDA Approved: ACTONEL — Supplemental Application (Allergan, Inc.)
FDA approved a supplemental application for Actonel (risendronate sodium) filed by Allergan, Inc., to update the labeling related to its app…
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FDA approval · 2010-08-24FDA Approved: ALENDRONATE SODIUM — Supplemental Application (Aurobindo Pharma Limited)
The FDA approved a supplemental application for alendronate sodium from Aurobindo Pharma Limited, enabling the marketing of a generic produc…
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CLINICAL_TRIALS trial_result · 2010-06-14Clinical Trial Update: Bioequivalence Study of Alendronate Sodium Tablets 70 mg of Dr. Reddy's Under Fasting Conditions [Phase 1]
This entry reports the completion of a Phase 1 bioequivalence study of Dr. Reddy's Alendronate Sodium 70 mg tablets under fasting conditions…
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FDA approval · 2010-04-22FDA Approved: ALENDRONATE SODIUM — Supplemental Application (Amneal Pharmaceuticals of New York LLC)
FDA approved a supplemental application for ALENDRONATE SODIUM submitted by Amneal Pharmaceuticals of New York LLC.
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CLINICAL_TRIALS trial_result · 2010-03-02Clinical Trial Update: Can Parathyroid Hormone Injections Reverse Glucocorticoid-induced Osteoporosis [Phase 2]
Phase 2 results from a trial of parathyroid hormone injections in glucocorticoid-induced osteoporosis have been reported. The study is compl…
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FDA label_change · 2009-12-31FDA Approved: ACTONEL — Supplemental Application (Allergan, Inc.)
FDA approved Allergan's supplemental NDA for Actonel (risendronate sodium) to update the labeling, potentially adding or revising indication…
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FDA approval · 2009-09-24FDA Approved: ALENDRONATE — Original Application (Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd.)
FDA approved Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd.'s generic alendronate (alendronate sodium tablets) via an Original Applicat…
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FDA approval · 2009-07-23FDA Approved: ACTONEL — Supplemental Application (Allergan, Inc.)
FDA approved a supplemental application for Actonel (risendronate sodium) from Allergan, Inc., approving changes to the product labeling und…
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CLINICAL_TRIALS trial_result · 2009-02-13Clinical Trial Update: Comparison of Teriparatide With Alendronate for Treating Glucocorticoid-Induced Osteoporosis [Phase 3]
A Phase 3 trial comparing teriparatide with alendronate for glucocorticoid-induced osteoporosis completed, with results posted in 2009.
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FDA approval · 2008-10-08FDA 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 · 2008-08-04FDA Approved: ALENDRONATE SODIUM — Original Application (EXELAN PHARMACEUTICALS INC.)
FDA approved the original application for alendronate sodium (Exelan Pharmaceuticals Inc.), making this generic osteoporosis therapy availab…
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FDA approval · 2008-08-04FDA Approved: ALENDRONATE SODIUM — Original Application (Aurobindo Pharma Limited)
FDA approves the original application for alendronate sodium from Aurobindo Pharma Limited as a generic therapy.