13 Drugs Facing FDA Approval Decisions

Here is the updated list of drugs facing FDA approval decisions.
Publish date:



) -- For FDA drug approval decision junkies, October is your World Cup.

By my count, U.S. regulators will issue approval decisions on 13 different drugs during October, making it the busiest month on the FDA calendar by a large margin. The summer -- when news flow in the biotech sector slows down and investor interest wanes -- is a good time to start thinking about the uptick of biotech catalysts in the fall.

For this June update to my regular FDA regulatory calendar, I've highlighted the 13 drugs (impacting 19 different companies) awaiting approval decisions in October. Stocks are listed in chronological order, starting with the earliest FDA approval decision date.

Read on.

Johnson & Johnson

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Nucynta for moderate to severe chronic pain

Approval decision date:

Oct. 1

This is a extended release formulation of Nucynta with certain abuse-resistant properties. An immediate-release version of the painkiller was approved in 2008.

Javelin Pharmaceuticals



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.

The acquisition of Javelin by



is currently stalled and heading to court.

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.



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

Jazz Pharmaceuticals

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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.


(ALKS) - Get Report


Vivitrol for opioid addiction

Approval decision date:

Oct. 12

If approved, Vivitrol will be the first long-acting, non-narcotic treatment for patients addicted to opioids. Alkermes currently sells a version of Vivitrol for alcholol dependence.

Amylin Pharmaceuticals




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Eli Lilly

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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

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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.

Protalix BioTherapeutics

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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



Cerezyme and



Vpriv, both already approved.


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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 14.

Bristol-Myers Squibb

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Onglyza/metformin for diabetes

Approval decision date:

Oct. 29

Onglyza/metformin is a once-daily fixed dose combination of two drugs to treat diabetes patients.




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.

Avanir Pharmaceuticals



Zenvia for pseudobulbar effect

Approval decision date:

: Oct. 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.

-- Reported by Adam Feuerstein in Boston.

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