Postmenopausal Osteoporosis
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Sign up freeTop drugs studied for this disease
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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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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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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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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,…
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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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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 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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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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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…