Blockbuster FDA Decisions In The Next Few Months--FDA Calendar Predictions

FDA's Upcoming Blockbuster Drug Decisions for Q4 2010

October 11, 2010

Again I am predicting the upcoming FDA Calendar for the next upcoming months for the Fourth Quarter.  This is just an initial walkthrough of all the upcoming decisions.  Lets see how well I do.  I am doing pretty well from October's FDA calendar. 

The FDA has some of its biggest decisions of the year looming in the next few months. The first new lupus drug in half a century, a blood-thinner with mega-blockbuster potential, controversial weight drugs and more are all up for regulatory decisions that can move markets and either throw a bucket of cold water or high octane gasoline on stock prices.

In every case, BioPharma Investor has been following the deals and data every step of the way--from early-stage development right through to the NDA and deal-making phases. Now everyone faces the moment of truth, or at least a complete response letter.

The FDA's final decision may be signaled by an expert panel vote, but this is one area where there really is no sure thing. The agency has appeared to be taking a tough stance on safety, which has bedeviled some late-stage therapies. And its complete response letters are always opened with a mix of dread and hope. We've seen plenty of surprising decisions so far this year, and there will likely be more in the months ahead.

I have to do some more research on my Approval Decisions---Here is an preliminary list of FDA Approvals coming in the 4th Quarter of 2010.  This is just an estimated guess off the top of my head.  Some are toss-ups.  The FDA is leaning more on the Complete Response Letter side which isn't necesarily a death sentence as why the drug was not approved and how it might be possible to get approval.  Usually, it requires more Clinical Trials when a company receives a CRL from the FDA.

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FDA Calendar Predictions

Comprehensive List of Drugs Approved During the Summer 2010

I found this nice list of 2010 drug approvals on The Health Wisdom Blog.  This probably is the most informative posting on Drug Approvals from 2010.


Glaxo (GSK), Merck (MRK), Novartis (NVS), Sanofi-Aventis (SNY), and Amgen (AMGN)  were again at the top on these approvals.

New Drugs Approved Summer 2010

New drugs not only offer hope, but possibly a better quality of life, for those awaiting new treatments. However, new drug approvals can also spark controversy. The FDA approved 17 new drugs this summer (June-August 2010). Many offer new promise, and one in particular promises a great deal of future debate.