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Symlin Complete Response Follows "Emerging Consensus" On Hypoglycemia

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Amylin expects its hypoglycemia re-analysis to mitigate FDA’s concerns about its pending antidiabetic Symlin, the company says.

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Diabetes Drug Advances Are Highlight Of NMEs Pending In 2005

Highlights of NME class of 2005 could be advances in diabetes, with Lilly/Amylin’s exenatide and Amylin’s Symlin currently being reviewed and Pfizer’s inhaled insulin Exubera slated for filing early in the year. Other major pending NMEs include J&J’s dapoxetine for premature ejaculation and Solvay’s irritable bowel syndrome agent Calmactin (cilansetron)

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