Glucocorticoid-induced Osteoporosis
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Sign up freeTop drugs studied for this disease
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FDA approval · 2016-07-14FDA Approved: ZOLEDRONIC ACID — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)
The FDA approved a supplemental application for a generic zoledronic acid product from Heritage Pharmaceuticals (d/b/a Avet Pharmaceuticals)…
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FDA approval · 2016-03-29FDA Approved: ALENDRONATE SODIUM — Supplemental Application (Amneal Pharmaceuticals of New York LLC)
The FDA approved a supplemental application for alendronate sodium from Amneal Pharmaceuticals of New York LLC. This action indicates regula…
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FDA approval · 2016-03-22FDA Approved: BINOSTO — Supplemental Application (Radius Health, Inc.)
The FDA approved a supplemental application for Binosto (alendronate sodium) from Radius Health, Inc., updating the product labeling as part…
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FDA approval · 2016-02-12FDA Approved: ALENDRONATE SODIUM — Supplemental Application (EXELAN PHARMACEUTICALS INC.)
FDA approved a supplemental application for alendronate sodium from Exelan Pharmaceuticals Inc. under the ANDA program.
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FDA approval · 2015-12-15FDA Approved: RISEDRONATE SODIUM — Supplemental Application (Apotex Corp.)
FDA approved a supplemental application for risendronate sodium submitted by Apotex Corp., resulting in an approved change to the marketed p…
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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: FOSAMAX — Supplemental Application (Organon LLC)
FDA approved a supplemental application for FOSAMAX (alendronate sodium) from Organon LLC.
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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 · 2015-09-23FDA 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 · 2015-07-22FDA 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 · 2015-06-08FDA 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 approval · 2015-03-26FDA Approved: ACTONEL — Supplemental Application (Allergan, Inc.)
The FDA approved a supplemental application for Actonel (risedronate sodium) submitted by Allergan, expanding its labeling for additional os…
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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 · 2014-06-10FDA 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 · 2013-12-23FDA 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 · 2013-08-30FDA Approved: TERIPARATIDE — Supplemental Application (Prasco Laboratories)
FDA has approved a supplemental application for teriparatide submitted by Prasco Laboratories, related to the NDA 021318 product.
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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 · 2013-08-02FDA Approved: TERIPARATIDE — Supplemental Application (Prasco Laboratories)
FDA approved a supplemental application for teriparatide submitted by Prasco Laboratories, authorizing its marketing.
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FDA approval · 2013-07-15FDA Approved: ALENDRONATE SODIUM — Supplemental Application (Amneal Pharmaceuticals of New York LLC)
The FDA approved a supplemental application for alendronate sodium, manufactured by Amneal Pharmaceuticals of New York LLC. This action appr…
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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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FDA approval · 2013-03-29FDA 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.