The FDA has just released its report on Novel New Drugs approved for 2014.
http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DrugInnovation/UCM430299.pdf
Of particular note:
Fast Track
Seventeen of the 2014 novel new drugs (41%) were designated by CDER as Fast Track, meaning drugs with the
potential to address unmet medical needs. Fast Track speeds new drug development and review, for instance, by
increasing the level of communication FDA allocates to drug developers and by enabling CDER to review portions
of a drug application ahead of the submission of the complete application.
1. BELEODAQ 4. ENTYVIO 7. IMPAVIDO 10. OFEV 13. VIEKIRA PAK 16. ZONTIVITY
2. CYRAMZA 5. ESBRIET 8. MYALEPT 11. OPDIVO 14. VIMIZIM 17. ZYDELIG*.
3. DALVANCE 6. HARVONI 9. NORTHERA 12. RAPIVAB 15. ZERBAXA
Great to see the benefits of obtaining fast track designation (IMO - DYOR)
The FDA has just released its report on Novel New Drugs approved...
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