ENDOCRINOLOGIC AND METABOLIC DRUGS ADVISORY COMMITTEE

July 26, 2001

SYMLIN Injection (Pramlintide acetate) NDA no. 21-332

Briefing Information

Amylin Pharmaceuticals   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 Backgrounder 

SYMLIN Injection (Pramlintide acetate) NDA no. 21-332

Briefing Information

FDA Backgrounder

Preface to FDA Backgrounder   pdf

Medical Review Efficacy   pdf   htm

Medical Review Safety   pdf   htm

Statistics   pdf

Pharmacology   pdf   htm

Pharmacology & Toxicology Summary   pdf