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Risk Evaluation and Mitigation Strategies (REMS) Letters to Sponsor/Applicants Requesting Labeling Changes


Bisphosphonates (10/13/2010)

  • Actonel (risedronate sodium) Tablets (PDF - 95KB)
  • Actonel with Calcium (risedronate sodium and calcium carbonate) Tablets (PDF - 84KB)
  • Atelvia (risedronate sodium) Delayed-Release Tablets (PDF - 92KB)
  • Boniva (ibandronate sodium) Injection (PDF - 91KB)
  • Boniva (ibandronate sodium) Tablets (PDF - 84KB)
  • Fosamax (alendronate sodium) Tablets and Oral Solution (PDF - 83KB)
  • Fosamax Plus D (alendronate sodium and cholecalciferol) Tablets (PDF - 91KB)
  • Reclast (zoledronic acid) Injection (PDF - 93KB)



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