Hypercalcemia of Malignancy
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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 label_change · 2015-10-08FDA Approved: ZOLEDRONIC ACID — Supplemental Application (Sagent Pharmaceuticals)
FDA supplemental application for Zoledronic Acid submitted by Sagent Pharmaceuticals to modify the drug's labeling.
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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 · 2015-05-27FDA Approved: ZOLEDRONIC ACID — Supplemental Application (BPI Labs LLC)
FDA approved a supplemental application for zoledronic acid from BPI Labs LLC under an ANDA.
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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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EMA safety_alert · 2015-03-13PRAC recommends further measures to minimise risk of osteonecrosis of the jaw with bisphosphonate medicine
PRAC recommends additional measures to reduce the risk of osteonecrosis of the jaw associated with bisphosphonate medicines.
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CLINICAL_TRIALS trial_result · 2015-01-01Clinical Trial Update: Study of Denosumab in the Treatment of Hypercalcemia of Malignancy in Subjects With Elevated Serum Calcium [Phase 2]
Phase 2 trial evaluating denosumab for hypercalcemia of malignancy in cancer patients; study completed with results posted.
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CLINICAL_TRIALS withdrawal · 2014-12-05Clinical Trial Update: One Week Comparison Study of PTH and PTHrP Infusions [Phase 1]
A Phase 1 trial evaluating infusions of parathyroid hormone (PTH) and parathyroid hormone-related peptide (PTHrP) for osteoporosis and relat…
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CLINICAL_TRIALS withdrawal · 2013-11-13Clinical Trial Update: S0308 Zoledronate or Ibandronate in Preventing Bone Problems in Women With Stage IV Breast Cancer That Has Spread to the Bone [Phase 3]
Phase 3 trial evaluating zoledronic acid or ibandronate to prevent bone problems in women with stage IV breast cancer that has spread to bon…
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FDA approval · 2013-09-23FDA Approved: ZOLEDRONIC ACID — Original Application (Sagent Pharmaceuticals)
FDA approves a generic zoledronic acid injection from Sagent Pharmaceuticals under ANDA 202828, granting approval to market the product for …
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FDA approval · 2013-06-03FDA Approved: ZOLEDRONIC ACID — Original Application (Hikma Pharmaceuticals USA Inc.)
FDA approves Hikma Pharmaceuticals USA Inc.'s original application for a generic zoledronic acid injectable product.
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CLINICAL_TRIALS trial_result · 2013-05-15Clinical Trial Update: Monoclonal Antibody Compared With Zoledronate in Treating Women With Breast Cancer and Bone Metastases [Phase 1, Phase 2]
This clinical trial update reports Phase 1/2 results comparing an unnamed monoclonal antibody to zoledronic acid in women with breast cancer…
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FDA approval · 2013-03-29FDA Approved: ZOLEDRONIC ACID — Original Application (Dr.Reddy's Laboratories Ltd)
FDA approved the original application for Zoledronic acid (generic) from Dr. Reddy's Laboratories Ltd. This approval confirms a generic vers…
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FDA approval · 2013-03-04FDA Approved: ZOLEDRONIC ACID — Original Application (Mylan Institutional LLC)
FDA approved an original application for a zoledronic acid generic product manufactured by Mylan Institutional LLC.
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FDA approval · 2013-03-04FDA Approved: ZOLEDRONIC ACID — Original Application (Dr. Reddy's Laboratories Limited)
FDA approved Dr. Reddy's Laboratories Limited's zoledronic acid under an original application, enabling a generic version of the drug.
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CLINICAL_TRIALS trial_result · 2013-02-21Clinical Trial Update: Zoledronate in Treating Patients With Solid Tumors That Have Spread to the Bone [Phase 3]
Phase 3 trial of zoledronic acid in patients with solid tumors and bone metastases has completed, including cases with hypercalcemia of mali…
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FDA approval · 2011-01-25FDA Approved: RECLAST — Supplemental Application (Sandoz Inc)
The FDA approved a supplemental application for RECLAST (zoledronic acid) filed by Sandoz Inc.
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FDA approval · 2009-05-13FDA Approved: PAMIDRONATE DISODIUM — Supplemental Application (Mylan Institutional LLC)
FDA approved a supplemental application for pamidronate disodium by Mylan Institutional LLC under an ANDA.
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FDA approval · 2006-05-19FDA Approved: PAMIDRONATE DISODIUM — Supplemental Application (Hospira, Inc.)
FDA approved Hospira's supplemental application for pamidronate disodium, confirming the regulatory approval for the product.