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21 Drugs Facing FDA Approval Decisions

Human Genome Sciences (HGSI)

Drug/indication: Zalbin for hepatitis C

Approval decision date: Oct. 4, 2010

Recent stock performance: At just under $30, the stock has rebounded 35% off its July low but is still just flat for the year.

In June, Human Genome Sciences said approval of Zalbin was unlikely after the FDA expressed concerns about the risk-benefit of the drug. Zalbin is a longer-acting formulation of interferon that can be dosed as infrequently as every two weeks for the treatment of hepatitis C. Currently approved long-acting interferons require once-weekly dosing.


Alexza Pharmaceuticals (ALXA)

Drug/indication: AZ-004 for agitation in patients with schizophrenia or bipolar disorder

Approval decision date: Oct. 11, 2010

Recent stock performance: At around $3, stock is still far from the 52-week high of nearly $4 reached in May.

AZ-004 is an inhaled formulation of the generic antispsychotic drug loxapine, intended for the rapid treatment of adults with schizophrenia or bipolar disorder. Biovail (BVF) will market AZ-004 in the U.S. and Canada, if approved.


Jazz Pharmaceuticals (JAZZ)

Drug/indication: JZP-6 for fibromyalgia

Approval decision date: Oct. 11, 2010

Recent stock performance: Shares tumbled to around $8.50 from more than $10 after the negative FDA advisory panel vote.

On July 20, an FDA advisory panel voted against approval of JZP-6 due to unacceptable risks of the drug being misused and potentially abused. JZP-6 contains the same active ingredient as Xyrem, which Jazz currently markets in the U.S. as a treatment for excessive daytime sleepiness and cataplexy in adult patients with narcolepsy.

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