Postmarket Drug Safety Information for Patients and Providers > Risk Evaluation and Mitigation Strategies (REMS) Letters to Sponsor/Applicants Requesting Labeling Changes

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)


Metoclopramide

Metoclopramide (NDA Reglan tablets and injection) (PDF - 61KB)Metoclopramide (ANDA Oral solution USP, 5 mg/5 mL) (PDF - 59KB)

full-text and links:
Postmarket Drug Safety Information for Patients and Providers > Risk Evaluation and Mitigation Strategies (REMS) Letters to Sponsor/Applicants Requesting Labeling Changes