Postmenopausal Osteoporosis
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Sign up freeTop drugs studied for this disease
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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 · 2015-11-30FDA Approved: RISEDRONATE SODIUM — Original Application (Sun Pharmaceutical Industries, Inc.)
The FDA approved Sun Pharmaceutical Industries' risendronate sodium generic product under an Original Application (ANDA). Risendronate sodiu…
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FDA approval · 2015-11-23FDA Approved: TERIPARATIDE — Supplemental Application (Prasco Laboratories)
The FDA approved a supplemental application for teriparatide submitted by Prasco Laboratories.
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FDA approval · 2015-10-31FDA Approved: CALCITONIN SALMON — Supplemental Application (Apotex Corp.)
FDA approved a supplemental application from Apotex Corp. for calcitonin salmon (generic), resulting in an updated approval under the ANDA p…
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FDA approval · 2015-10-31FDA Approved: CALCITONIN SALMON — Supplemental Application (Endo USA, Inc.)
FDA approved a supplemental application for Calcitonin Salmon submitted by Endo USA, Inc.
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CLINICAL_TRIALS trial_result · 2015-09-28Clinical Trial Update: Wellnara Post-marketing Surveillance in Japan
Bayer's Wellnara post-marketing surveillance study in Japan on osteoporosis (postmenopausal) has completed, collecting real-world safety and…
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FDA approval · 2015-09-25FDA Approved: DUAVEE — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)
The FDA approved a supplemental application for DUAVEE (conjugated estrogens/bazedoxifene) from Wyeth Pharmaceuticals LLC (Pfizer) to suppor…
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FDA approval · 2015-09-23FDA Approved: ALENDRONATE SODIUM — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for alendronate sodium by Hikma Pharmaceuticals USA Inc., adding regulatory approval status for this…
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CLINICAL_TRIALS trial_result · 2015-09-09Clinical Trial Update: Switching From Oral Bisphosphonates to Bazedoxifene to Evaluate Effects on Bone Mineral Density in Postmenopausal Women [Phase 4]
Phase 4 trial evaluating switching from oral bisphosphonates to bazedoxifene and its effects on bone mineral density in postmenopausal women…
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FDA approval · 2015-09-02FDA Approved: IBANDRONATE SODIUM — Supplemental Application (Mylan Institutional LLC)
FDA approved a supplemental application for ibandronate sodium submitted by Mylan Institutional LLC (ANDA 202671), indicating approved chang…
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FDA approval · 2015-08-31FDA Approved: PREMPRO — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)
FDA approved a supplemental application for PREMPRO (conjugated estrogens and medroxyprogesterone acetate) from Wyeth Pharmaceuticals (Pfize…
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CLINICAL_TRIALS withdrawal · 2015-08-27Clinical Trial Update: Efficacy and Safety of Odanacatib in Postmenopausal Women Previously Treated With Alendronate (MK-0822-050) [Phase 3]
The Phase 3 trial MK-0822-050 evaluating odanacatib in postmenopausal osteoporosis previously treated with alendronate has been withdrawn.
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CLINICAL_TRIALS trial_result · 2015-08-18Clinical Trial Update: SUMMIT Study: A Study of Persistence to Bonviva (Ibandronate) Once Monthly in Women With Post-Menopausal Osteoporosis. [Phase 4]
This Phase 4 trial update reports completion of the SUMMIT study evaluating monthly persistence to Bonviva (ibandronate) in women with postm…
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CLINICAL_TRIALS trial_result · 2015-08-13Clinical Trial Update: A Study of Bonviva/Boniva (Ibandronate) in Biphosphonate-Naïve Women With Post-Menopausal Osteoporosis [Phase 3]
Phase 3 trial results for ibandronate (Boniva) in bisphosphonate-naïve postmenopausal osteoporosis have been completed and posted.
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FDA approval · 2015-07-24FDA Approved: IBANDRONATE SODIUM — Supplemental Application (Apotex Corp)
FDA approved a supplemental application for ibandronate sodium from Apotex Corp.
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FDA approval · 2015-07-23FDA Approved: DUAVEE — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)
FDA approved a supplemental application for Duavee (conjugated estrogens/bazedoxifene) to update the labeling, potentially expanding its app…
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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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CLINICAL_TRIALS trial_result · 2015-07-22Clinical Trial Update: A Study Comparing Monthly Boniva (Ibandronate) and Weekly Risedronate in Women With Post-Menopausal Osteoporosis. [Phase 4]
Results from a Phase 4 study comparing monthly ibandronate (Boniva) to weekly risedronate in women with postmenopausal osteoporosis; the tri…
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FDA approval · 2015-07-16FDA 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 (ANDA075710).
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FDA approval · 2015-07-15FDA Approved: IBANDRONATE SODIUM — Supplemental Application (Dr. Reddy's Laboratories Limited)
FDA approves a supplemental application for ibandronate sodium from Dr. Reddy's Laboratories Limited. The action confirms approval of this g…
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FDA approval · 2015-07-15FDA Approved: IBANDRONATE SODIUM — Supplemental Application (Bionpharma Inc.)
FDA approves a supplemental application for ibandronate sodium from Bionpharma Inc.
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FDA approval · 2015-07-10FDA Approved: FOSAMAX PLUS D — Supplemental Application (Organon LLC)
FDA approved a supplemental application for Fosamax Plus D (alendronate sodium and cholecalciferol) from Organon LLC. The approval updates t…
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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 · 2015-06-08FDA Approved: COMBIPATCH (ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM) — Supplemental Application (Noven Therapeutics, LLC)
FDA approved a supplemental application for Combipatch (estradiol/norethindrone acetate transdermal system) submitted by Noven Therapeutics,…