CARDIOVASCULAR & RENAL DRUGS ADVISORY COMMITTEE
August 9, 2001
Remodulin (treprostinil sodium) Injection NDA 21-272
Briefing Information
United Therapeutics Corporation pdf
Disclaimer
The statements contained in this document are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.
FDA Briefing
Medical Officer Review pdf htm
Statistical Review and Evaluation Amendment pdf htm
Statistical Review and Evaluation pdf htm
Biopharmaceutics Review pdf doc
Note to Advisory Committee Members pdf htm
March 9, 2001 Memo from Director, office of Drug Evaluation and Review pdf htm
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Extraneal (75% Icodextrin) Peritoneal Dialysis Solution NDA 21-321
Baxter HealthCare Corporation pdf
Disclaimer
The statements contained in this document are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.
FDA Briefing
Statistical Review and Evaluation pdf htm
Clinical Pharmacology & Biopharmaceutics Review pdf htm