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Although new molecular entity approvals in the United States dropped from 26 in 2009 to 21 in 2010, the percentage of NME approvals cleared for marketing versus the number of such filings markedly improved year-over-year. FDA’s Center for Drug Evaluation and Research approved 21 out of 23 (91.3%) NME submissions in 2010 as opposed to 26 out of 37 (70.3%) for 2009. Partly due to FDA’s continued push for more stringent product-safety standards in recent years, the annual amount of NME approvals from 2005-2010 ranged from the high teens to mid twenties versus 36 in 2004.
New Drug Review and Outlook 2011 is presented in the following four sections.
Products Awaiting FDA Clearance
FDA's New Medicines of 2010
U.S. Approvals Over Time
What you will find in this special report:
In the first part, analysis is provided regarding some of the most-anticipated products expected to emerge from the late stages of the industry pipeline. The second segment presents a listing of new drugs awaiting first-time FDA approval. The report’s third portion contains an overview of the 88 new prescription medicines that were approved via a new drug application (NDA) or biologic license application (BLA) in the United States during 2010. The fourth sector of this report lists in alphabetical order the products that have been approved by FDA via an NDA or BLA since 1990.