) -- Welcome to
first-ever FDA Drug Approval Predictions Contest.
Your challenge: Correctly predict the approval decisions to be made by the U.S. Food and Drug Administration on 11 new drugs in October. The lawyers (party poopers) won't let us offer a prize without official rules, contracts, etc., so the person(s) with the most accurate predictions will, instead, receive a hearty congratulations, a mention in a future column and bragging rights as the best FDA drug-approval prognosticator in all the land.
To simplify the contest, you have three outcomes to choose from for each drug approval decision:
: The big win, meaning the drug is approved and can be marketed for sale immediately.
Complete Response Letter
: FDA has some concerns or issues (incomplete data, labeling, risk management, etc.) that prevent the drug from being approved immediately. In other words, the drug's approval is delayed for some reason.
: FDA chooses to extend the drug's review time, i.e., pushes out the approval decision to a later date. With the FDA looking at an unprecedented number of approval decisions in such a short time period, it won't be surprising to see some of these drug approvals delayed.
The 11 drugs up for FDA approval are listed below in chronological order. Again, please use one of three choices for your prediction: Full Approval, Complete Response Letter or No Decision.
FDA Drug Approval Prediction Contest, please copy the drug list, write in your approval prediction, and post your predictions using the "Add Comment" button found at the top or bottom of this Web page. You'll need to complete a short registration to post a comment --
make sure you include a valid email address
so we can contact the winners.
Entries received after the start of October are eligible for the contest, but you won't get credit for drug-approval decisions already made by the time your entry was received.
Pending FDA Drug Approval Decisions:
Dyloject for acute moderate to severe pain in adults.
Human Genome Sciences'
Zalbin for hepatitis C.
(ALXA - Get Report)
AZ-004 for agitation in patients with schizophrenia or bipolar disorder.
(JAZZ - Get Report)
JZP-6 for fibromyalgia.
(ALKS - Get Report)
Vivitrol for opioid addiction.
(ARNA - Get Report)
lorcaserin for obesity.
, Alkermes and
Bydureon for diabetes.
Qnexa for obesity.
Zenvia for pseudobulbar affect.
ceftaroline for Community Acquired Pneumonia. Oct. 30
Linjeta for diabetes.
--Written by Adam Feuerstein in Boston.
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