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New Molecular Entities Approved In 2010

This article was originally published in Pharmaceutical Approvals Monthly

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Second Consecutive Year Of Growth In NME Approvals In The Cards For FDA

It looks to be a good bet that 2009 will mark a second year of growth in new drug approvals as FDA enters the second half of the year with a robust first-half NME approval tally and a well-stocked pipeline of novel agents with user fee goal dates in the remaining months of the year.

NME Slump Continues: FDA Clears 18 Novel Drugs In 2006, Same As 2005

FDA's final approval tally of new molecular entities in 2006 is almost a 25-year low, despite early signs that the agency was on pace to best last year's final count of NME approvals

FDA’s 2005 New Molecular Entity Total: 18, Including Five In December

FDA clearance of Bayer/Onyx’ Nexavar oncologic Dec. 20, ahead of its Jan. 11, 2006 user fee goal date, helped the agency achieve a total of 18 new molecular entity approvals in 2005.

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