Clinical Review

APPENDIX SUBSECTION 6.1

MedWatch Forms for Cases of Special Interest

 

 

CRESTOR (ZD4522, rosuvastatin calcium) Tablets

FDA Advisory Committee Meeting Briefing Document NDA 21-366 for the use of CRESTOR

June 11, 2003

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6.1 MedWatch Forms for Cases of Special Interest:

 

1.     MedWatch Report of a case of 68 year old patient with Jaundice and Transaminase elevation on 10mg of Rosuvastatin D3560L0001/0310/01237

2.     MedWatch Report of a case of 73 year old patient with Jaundice and Transaminase elevation on 10mg of Rosuvastatin D3560L0001/2265/09060

3.     MedWatch Report of a case of Rhabdomyolysis on 10mg of Rosuvastatin 2003SE02255

4.     MedWatch Report of a case of 46 year old patient with Renal Failure on 80mg of Rosuvastatin 0065/0044/0014

5.     MedWatch Report of a case of 70 year old patient with Renal Failure on 80mg of Rosuvastatin 0065/0026/0049

6.     MedWatch Report of a case of 69 year old patient with Interstitial Nephritis on 80mg of Rosuvastatin 0034/0316/0025