Drugs
-
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)
-
-