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14 Biotech Stocks Facing FDA Approval:

BOSTON (TheStreet) -- News of a drug's approval or rejection from the U.S. Food and Drug Administration can rock or kill a biotech stock's price. Here is an updated FDA calendar that shows 14 companies -- in chronological order -- with drugs facing FDA approval decisions through October 2010.

Cell Therapeutics (CTIC)

Drug/indication: Pixantrone for non-Hodgkin's lymphoma

Approval decision date: April 23

An FDA advisory panel held on March 22 voted 9-0 to recommend against approval of pixantrone.



Pozen (POZN)

Drug/indication: Vimovo for pain relief

Approval decision date: April 30

Vimovo combines an acid inhibitor with a non-steroidal anti-inflammatory drug in a single tablet, intended to provide pain relief with fewer gastrointestinal side effects. AztraZeneca(AZN) is Pozen's marketing partner for Vimovo.



Dendreon (DNDN)

Drug/indication: Provenge for prostate cancer

Approval decision date: May 1

The FDA has given no indication that it plans to hold an advisory panel meeting to review the Provenge application. A similar panel meeting was held in 2007, which voted to recommend the drug's approval.



InterMune (ITMN)

Drug/indication: Pirfenidone for idiopathic pulmonary fibrosis

Approval decision date: May 4

An FDA advisory panel held March 9 voted to recommend the approval of pirfenidone for the treatment of idiopathic pulmonary fibrosis. The positive vote sent InterMune shares higher.



Questcor Pharmaceuticals (QCOR)

Drug/indication: Acthar for infantile spasms

Approval decision date: June 11

Prior to the FDA's approval decision date, an FDA advisory panel will review the safety and efficacy of Acthar on May 6. The FDA's review of Acthar is expected to post to the agency's web site on May 4 or May 5.



Novartis (NVS)

Drug/indication: Gilenia for multiple sclerosis

Approval decision date: June 2010 (Novartis has not disclosed the exact date.)

The FDA is holding an advisory committee meeting on June 10 to review Gilenia. If approved, Gilenia would be the first multiple sclerosis drug administered as a pill, and as such, the drug could have an impact on already approved, injectable MS drugs from Biogen Idec(BIIB), Teva(TEVA) and Merck-Serono.



Savient Pharmaceuticals (SVNT)

Drug/indication: Krystexxa for gout

Approval decision date: Sept. 14

The FDA refused to approve Krystexxa last August, citing problems with the way the drug is manufactured. Savient revised the Krystexxa manufacturing process and submitted a response in March to the FDA's complete response letter.



Javelin Pharmaceuticals (JAV)

Drug/indication: Dyloject for acute moderate-to-severe pain in adults

Approval decision date: Oct. 3

If approved, Dyloject will be the first IV non-steroidal anti-inflammatory drug (NSAID) marketed in the U.S. as a single agent for the management of acute moderate-to-severe pain in adults since ketorolac in 1990. The active ingredient in Dyloject is diclofenac sodium, a widely prescribed oral NSAID.



Human Genome Sciences (HGSI)

Drug/indication: Zalbin for hepatitis C

Approval decision date: Oct. 4

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 required once-weekly dosing.



Alexza Pharmaceuticals (ALXA)

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

Approval decision date: Oct. 11

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

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.



Arena Pharmaceuticals (ARNA)

Drug/indication: Lorcaserin for obesity

Approval decision date: Oct. 22

Lorcaserin is one of three obesity drugs currently under review by the FDA. Regulators have not yet indicated whether Arena will be required to bring lorcaserin in front of an advisory panel.



Vivus (VVUS)

Drug/indication: Qnexa for obesity

Approval decision date: October 28

The FDA has scheduled an advisory committee meeting on July 15 to review Qnexa's safety and efficacy as a weight-loss drug. The FDA's review of Qnexa will be posted to the agency's web site on July 13 or July 14.



Biodel (BIOD)

Drug/indication: VIAject for diabetes

Approval decision date: Oct. 30

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



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