Paget Disease of Bone
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Sign up freeTop drugs studied for this disease
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EMA approval · 2026-04-20EMA Authorised: Aclasta (zoledronic acid) — Sandoz Pharmaceuticals d.d.
The EMA authorised Sandoz's Aclasta (zoledronic acid) for osteoporosis indications, including postmenopausal osteoporosis and Paget disease …
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FDA approval · 2026-04-15FDA Approved: ALENDRONATE SODIUM — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for ALENDRONATE SODIUM submitted by Aurobindo Pharma Limited.
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FDA approval · 2026-03-04FDA Approved: CALCITONIN SALMON — Original Application (Zydus Pharmaceuticals USA Inc.)
FDA approves Zydus Pharmaceuticals USA Inc.'s Original Application for Calcitonin Salmon, a generic version of the established drug. This ap…
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FDA approval · 2026-02-03FDA Approved: ALENDRONATE SODIUM — Supplemental Application (ANI Pharmaceuticals, Inc.)
The FDA approved ANI Pharmaceuticals' supplemental application for alendronate sodium, updating the approved product under the ANDA.
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FDA approval · 2025-09-26FDA Approved: CALCITONIN SALMON — Original Application (Amneal Pharmaceuticals LLC)
FDA approved Amneal Pharmaceuticals' original application for Calcitonin Salmon (generic), marking the entry of a generic calcitonin product…
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FDA approval · 2024-12-05FDA Approved: CALCITONIN SALMON — Original Application (Fresenius Kabi USA, LLC)
FDA approved Fresenius Kabi USA, LLC's Calcitonin Salmon as an original application (ANDA 212675), enabling the marketing of this generic ca…
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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 · 2024-04-11FDA Approved: CALCITONIN SALMON — Original Application (Dr. Reddy's Laboratories, Inc.)
FDA approved the original application for Calcitonin Salmon from Dr. Reddy's Laboratories, Inc., enabling the generic to enter the market.
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FDA approval · 2024-01-08FDA Approved: RISEDRONATE SODIUM — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
The FDA approved a supplemental application for risendronate sodium by Sun Pharmaceutical Industries, expanding or modifying its labeling un…
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FDA approval · 2023-12-18FDA Approved: RISEDRONATE SODIUM — Supplemental Application (Sun Pharmaceutical Industires Inc.)
The FDA approved a supplemental application for Risedronate Sodium submitted by Sun Pharmaceutical Industries Inc.
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FDA approval · 2023-06-07FDA Approved: RISEDRONATE SODIUM — Supplemental Application (Macleods Pharmaceuticals Limited)
FDA approved a supplemental application for risendronate sodium from Macleods Pharmaceuticals Limited.
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FDA approval · 2023-06-06FDA Approved: ALENDRONATE SODIUM — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for ALENDRONATE SODIUM from Aurobindo Pharma Limited, enabling the approved generic formulation to b…
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FDA approval · 2023-06-05FDA Approved: ZOLEDRONIC ACID — Original Application (Meitheal Pharmaceuticals Inc.)
The FDA approved Meitheal Pharmaceuticals' original application for zoledronic acid, enabling a generic IV bisphosphonate product. This mark…
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FDA approval · 2023-05-12FDA Approved: RISEDRONATE SODIUM — Supplemental Application (Apotex Corp.)
FDA approved Apotex Corp.'s supplemental application for risendronate sodium (a generic osteoporosis medication) under ANDA090877.
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FDA approval · 2023-05-11FDA Approved: ALENDRONATE SODIUM — Original Application (ANI Pharmaceuticals, Inc.)
FDA approved ANI Pharmaceuticals' Original Application (ANDA) for alendronate sodium (ALENDRONATE SODIUM).
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FDA approval · 2023-01-31FDA 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 for use as a generic product …
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FDA approval · 2022-04-05FDA Approved: ZOLEDRONIC ACID — Supplemental Application (Sagent Pharmaceuticals)
The FDA approved a supplemental application for Zoledronic acid submitted by Sagent Pharmaceuticals, updating regulatory labeling per the su…
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FDA approval · 2022-02-22FDA Approved: IBANDRONATE SODIUM — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for ibandronate sodium filed by Aurobindo Pharma Limited, approving the generic product under the AN…
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FDA approval · 2021-11-10FDA Approved: CALCITONIN SALMON — Original Application (Par Health USA, LLC)
The FDA approved Par Health USA's generic Calcitonin Salmon under ANDA 209358.
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FDA approval · 2021-05-14FDA Approved: CALCITONIN SALMON — Original Application (Hikma Pharmaceuticals USA Inc.)
FDA approved Hikma Pharmaceuticals USA Inc.'s original application for a generic Calcitonin Salmon product (ANDA 212416).
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FDA approval · 2020-10-20FDA Approved: ZOLEDRONIC ACID — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for Zoledronic acid from Hikma Pharmaceuticals USA Inc., indicating regulatory approval for the spon…
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FDA approval · 2020-10-19FDA Approved: ZOLEDRONIC ACID — Supplemental Application (Mylan Institutional LLC)
FDA approved a supplemental application for zoledronic acid from Mylan Institutional LLC under an abbreviated new drug application (ANDA), e…
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FDA approval · 2020-08-26FDA Approved: CALCITONIN SALMON — Supplemental Application (Endo USA, Inc.)
The FDA approved a supplemental application for Calcitonin Salmon (Endo USA, Inc.), resulting in updated labeling for the product.
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FDA approval · 2020-08-06FDA Approved: RISEDRONATE SODIUM — Supplemental Application (Aurobindo Pharma Limited)
The FDA approved a supplemental application for Risendronate Sodium from Aurobindo Pharma Limited.
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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.