Avanir Pharmaceuticals ( AVNR)

Drug/indication: Zenvia for pseudobulbar effect

Approval decision date:: Oct. 30, 2010

Recent stock performance: At $3.04, stock is off its July high of $3.73.

FDA rejected Zenvia in 2006. Avanir conducted a new phase III study using a lower dose of the drug and resubmitted to FDA for another review.

Cadence Pharmaceuticals ( CADX)

Drug/indication: Ofirmev for pain/fever

Approval decision date: Nov. 4, 2010

Recent stock performance: At $8.21, stock is down 21% from its April high.

This is the second review cycle for Ofirmev following an FDA complete response letter issued in February.

Amgen ( AMGN)

Drug/indication:Prolia for bone complications in cancer patients

Approval decision date: Nov. 18, 2010

Recent stock performance: Amgen is down 8% for the year.

Prolia was previously approved as a treatment for osteoporosis. Amgen is seeking additional approvals for Prolia in various cancer indications.

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