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21 Drugs Facing FDA Approval Decisions

Amylin Pharmaceuticals (AMLN), Alkermes and Eli Lilly (LLY)

Drug/indication:Bydureon for diabetes

Approval decision date:Oct. 22, 2010

Recent stock performance: At just over $20 a share, Amylin is up 43% for the year.

This is the second FDA review cycle for Bydureon, a once-weekly injectable drug for diabetes.

Vivus (VVUS - Get Report)

Drug/indication: Qnexa for obesity

Approval decision date: October 28, 2010

Recent stock performance: At $5.61, Vivus' value was cut in half by the negative FDA advisory panel vote.

The odds in favor of Qnexa's approval took a big hit in July when an FDA advisory panel voted against the drug's approval due to a lack of long-term safety data. Vivus is expected to announce results from a two-year safety study of Qnexa in the third quarter.

Biodel (BIOD)

Drug/indication: VIAject for diabetes

Approval decision date: Oct. 29, 2010

Recent stock performance: Closed Friday at $3.88. The stock has traded as low as $3.22 and as high as $6.25 this year.

VIAject is a fast-acting insulin analogue designed for absorption into the bloodstream faster than currently marketed rapid-acting insulins.
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