14 Biotech Stocks Facing FDA Approval - TheStreet

(Updated with corrected FDA approval decision date for Avanir Pharmaceuticals, which is Oct. 30, not Oct. 27, as previously reported.)

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. This FDA regulatory calendar is an update to the

FDA approval calendar

posted on April 7 and includes information on four new stocks with approval decision dates scheduled through the end of October. The 14 stocks are listed in chronological order, starting with the earliest FDA approval decision date.

Questcor Pharmaceuticals



Acthar for infantile spasms

Approval decision date:

June 11

An FDA advisory panel said Acthar was safe and effective as a treatment for infant spasms at a meeting on May 6.

Glaxo's Radical Heart Drug (Forbes)


(NVS) - Get Report


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) - Get Report



(TEVA) - Get Report




Valeant Pharmaceuticals



Retigabine for epilepsy

Approval decision date:

August 30

If approved, Retigabine will be co-marketed by


(GSK) - Get Report


Savient Pharmaceuticals



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)


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



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 require once-weekly dosing.

Alexza Pharmaceuticals



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.


( BVF) will market AZ-004 in the U.S. and Canada, if approved.

Jazz Pharmaceuticals

(JAZZ) - Get Report


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.

Amylin Pharmaceuticals

( AMLN),


(ALKS) - Get Report


Eli Lilly

(LLY) - Get Report


Bydureon for diabetes

Approval decision date:

Oct. 22

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

Arena Pharmaceuticals

(ARNA) - Get Report


Lorcaserin for obesity

Approval decision date:

Oct. 22

Lorcaserin is one of three obesity drugs currently under review by the FDA. While not confirmed, an FDA advisory panel is expected to review lorcaserin at a meeting scheduled for Sept. 15-16.

Avanir Pharmaceuticals



Zenvia for pseudobulbar effect

Approval decision date:

October 30

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

Protalix BioTherapeutics

(PLX) - Get Report


Uplyso for Gaucher's disease

Approval decision date:

Oct. 27

Protalix was forced to submit additional Uplyso manufacturing data to the FDA, delaying the drug's approval.


(PFE) - Get Report

is Protalix's marketing partner for Uplyso, which will compete for Gaucher's patients with


( GENZ) Cerezyme and


( SHPGY) Vpriv, both already approved.


(VVUS) - Get Report


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.




VIAject for diabetes

Approval decision date:

Oct. 30

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

-- Reported by Adam Feuerstein in Boston.

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