Paget Disease of Bone
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Sign up freeTop drugs studied for this disease
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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 · 2015-10-31FDA 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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FDA label_change · 2015-10-23FDA Approved: RISEDRONATE SODIUM — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
The FDA approved a supplemental application for Risendronate Sodium from Sun Pharmaceutical Industries to update labeling for the generic os…
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FDA label_change · 2015-10-22FDA Approved: ACTONEL — Supplemental Application (Allergan, Inc.)
FDA overview documenting Allergan's supplemental application for Actonel (risendronate sodium) to update labeling.
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FDA approval · 2015-10-19FDA Approved: ZOLEDRONIC ACID — Supplemental Application (BPI Labs LLC)
FDA approves a supplemental application for zoledronic acid from BPI Labs LLC under ANDA 202930. This action supports continued availability…
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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 · 2015-09-21FDA Approved: ZOLEDRONIC ACID — Supplemental Application (Dr. Reddy's Laboratories Limited)
The FDA approved a supplemental application for zoledronic acid from Dr. Reddy's Laboratories Limited.
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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 · 2015-04-09FDA Approved: ZOLEDRONIC ACID — Supplemental Application (Dr.Reddy's Laboratories Ltd)
FDA approved a supplemental application for zoledronic acid from Dr. Reddy's Laboratories Ltd (ANDA 091363), granting regulatory approval of…
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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: FOSAMAX — Supplemental Application (Organon LLC)
FDA approved a supplemental application for Fosamax (alendronate sodium) submitted by Organon LLC.
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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 · 2015-02-02FDA Approved: MIACALCIN — Supplemental Application (Mylan Institutional LLC)
The FDA approved a supplemental application for Miacalcin (calcitonin salmon) submitted by Mylan Institutional LLC.
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FDA approval · 2015-01-30FDA Approved: RECLAST — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application for RECLAST (zoledronic acid) filed by Sandoz Inc., signaling a change to the product's labeling or …
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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 label_change · 2014-11-05FDA Approved: RISEDRONATE SODIUM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for risendronate sodium from Teva, indicating labeling changes to the generic product.
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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 label_change · 2014-05-13FDA Approved: RECLAST — Supplemental Application (Sandoz Inc)
The FDA approved a supplemental application for Reclast (zoledronic acid) filed by Sandoz Inc, typically to update the product labeling.