Osteoporosis in Men
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Sign up freeTop drugs studied for this disease
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FDA approval · 2025-10-29FDA Approved: ENOBY — Original Application (Hikma Pharmaceuticals USA Inc.)
FDA approved ENOBY (denosumab-qbde) from Hikma Pharmaceuticals USA Inc. via an original biologics license application. ENOBY is a denosumab …
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FDA approval · 2024-09-27FDA Approved: ALENDRONATE SODIUM — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for ALENDRONATE SODIUM by Aurobindo Pharma Limited (generic).
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FDA approval · 2024-04-09FDA Approved: PROLIA — Supplemental Application (Amgen, Inc)
The FDA approved Amgen's supplemental application for Prolia (denosumab). This action likely updates the drug's labeling.
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FDA approval · 2020-11-16FDA Approved: TERIPARATIDE — Supplemental Application (Prasco Laboratories)
FDA approved a supplemental application for teriparatide submitted by Prasco Laboratories, expanding or updating the drug's regulatory statu…
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FDA approval · 2020-10-13FDA Approved: BINOSTO — Supplemental Application (Radius Health, Inc.)
The FDA approved a supplemental application for BINOSTO (alendronate sodium) from Radius Health, Inc., supporting a label expansion/updated …
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FDA approval · 2020-06-08FDA Approved: BINOSTO — Supplemental Application (Radius Health, Inc.)
FDA approves a supplemental application for BINOSTO (alendronate sodium) submitted by Radius Health, Inc.
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CLINICAL_TRIALS trial_result · 2019-05-28Clinical Trial Update: A Study to Compare the Safety and Efficacy of Romosozumab (AMG 785) Versus Placebo in Men With Osteoporosis [Phase 3]
Phase 3 study comparing Romosozumab to placebo in men with osteoporosis has completed with results posted.
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FDA approval · 2019-02-15FDA Approved: RISEDRONATE SODIUM — Original Application (Hangzhou Minsheng Binjiang Pharmaceutical CO., Ltd)
FDA approved the generic drug risedronate sodium under an Original Application, expanding access to this bisphosphonate for osteoporosis- an…
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FDA approval · 2016-08-18FDA Approved: ZOLEDRONIC ACID — Original Application (Fresenius Kabi USA, LLC)
FDA approved an Original Application for Zoledronic acid as a generic injectable product from Fresenius Kabi USA, LLC. The approval covers i…
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FDA approval · 2016-05-24FDA Approved: RECLAST — Supplemental Application (Sandoz Inc)
The FDA approved a supplemental application for RECLAST (zoledronic acid) submitted by Sandoz Inc. The approval updates the product's labeli…
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FDA approval · 2015-12-09FDA Approved: RISEDRONATE SODIUM — Original Application (Macleods Pharmaceuticals Limited)
FDA approved the original application for risendronate sodium (generic risendronate) from Macleods Pharmaceuticals Limited.
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FDA approval · 2015-11-30FDA Approved: RISEDRONATE SODIUM — Original Application (Apotex Corp.)
FDA approved Apotex Corp.'s original ANDA for generic risedronate sodium (RISEDRONATE SODIUM), authorizing its marketing in the United State…
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FDA approval · 2015-07-22FDA Approved: ALENDRONATE SODIUM — Supplemental Application (Aurobindo Pharma Limited)
The FDA approved a supplemental application for alendronate sodium filed by Aurobindo Pharma Limited.
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FDA approval · 2015-06-08FDA Approved: PROLIA — Supplemental Application (Amgen, Inc)
FDA approved a supplemental application for PROLIA (denosumab) submitted by Amgen. This action approves changes to PROLIA's labeling/indicat…
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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 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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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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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 · 2013-03-13FDA 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 · 2013-02-25FDA 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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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 · 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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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.