Bone Metastases

• FDA approval · 2015-05-26
  FDA Approved: KIT FOR THE PREPARATION OF TECHNETIUM TC 99M MEDRONATE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for the kit used to prepare technetium-99m medronate for bone imaging, enabling regulatory approval …

• FDA approval · 2015-04-09
  FDA 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…

• FDA approval · 2015-02-27
  FDA Approved: SODIUM FLUORIDE F 18 — Original Application (Precision Nuclear LLC)

  The FDA approved the original application for Sodium Fluoride F-18, a PET radiotracer from Precision Nuclear LLC used for diagnostic bone im…

• FDA approval · 2013-09-23
  FDA 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 …

• FDA approval · 2013-06-28
  FDA Approved: SODIUM FLUORIDE F 18 — Original Application (Mayo Clinic)

  The FDA approved an Original Application for Sodium Fluoride F-18, a radiopharmaceutical used for bone imaging to detect metastatic bone dis…

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• FDA approval · 2013-03-29
  FDA 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…

• FDA approval · 2013-03-04
  FDA 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.

• FDA approval · 2011-09-23
  FDA Approved: TECHNETIUM TC 99M MEDRONATE — Supplemental Application (Jubilant DraxImage Inc., dba Jubilant Radiopharma)

  FDA approves a supplemental application for Technetium Tc-99m medronate (Medronate) from Jubilant Radiopharma, updating labeling to reflect …

• FDA approval · 2010-10-22
  FDA Approved: TECHNETIUM TC 99M MEDRONATE — Supplemental Application (Jubilant DraxImage Inc., dba Jubilant Radiopharma)

  FDA approved a supplemental application for Technetium Tc-99m Medronate (bone imaging agent) submitted by Jubilant DraxImage Inc., dba Jubil…

• FDA approval · 2009-05-13
  FDA Approved: PAMIDRONATE DISODIUM — Supplemental Application (Mylan Institutional LLC)

  FDA approved a supplemental application for pamidronate disodium by Mylan Institutional LLC under an ANDA.