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

Clinical Review   pdf   doc

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

Medical Reviews   pdf   htm

   Statistical Review and Evaluation   pdf   htm

Clinical  Pharmacology & Biopharmaceutics Review   pdf   htm