FDA/CDER Report on the Novel Drug Approvals in 2015

In calendar year 2015, the FDA’s Center for Drug Evaluation and Research (CDER) approved 45 novel drugs, approved as NMEs (new molecular entities) under New Drug Applications (NDAs) or as new therapeutic biologics under Biologics License Applications (BLAs).

From 2006 through 2014, CDER has averaged about 28 novel drug approvals per year.

Novel Drugs Approved by CDER in Calendar Year 2015

  1. Addyi
  2. Alecensa
  3. Aristada
  4. Avycaz
  5. Bridion
  6. Cholbam
  7. Corlanor
  8. Cosentyx
  9. Cotellic
  10. Cresemba
  11. Daklinza
  12. Darzalex
  13. Empliciti
  14. Entresto
  15. Farydak
  16. Genvoya
  17. Ibrance
  18. Kanuma
  19. Kengreal
  20. Kybella
  21. Lenvima
  22. Lonsurf
  23. Natpara
  24. Ninlaro
  25. Nucala
  26. Odomzo
  27. Orkambi
  28. Portrazza
  29. Praluent
  30. Praxbind
  31. Repatha
  32. Rexulti
  33. Savaysa
  34. Strensiq
  35. Tagrisso
  36. Tresiba
  37. Unituxin
  38. Uptravi
  39. Varubi
  40. Veltassa
  41. Viberzi
  42. Vraylar
  43. Xuriden
  44. Yondelis
  45. Zurampic

Download the Report in PDF

Download “2015 FDA CDER Novel Drug Approvals” UCM485053.pdf – Downloaded 153 times – 15 MB

First-in-Class (16 of the 45 novel drugs: 36%)

  1. Addyi
  2. Bridion
  3. Corlanor
  4. Cosentyx
  5. Darzalex
  6. Empliciti
  7. Entresto
  8. Ibrance
  9. Kanuma
  10. Nucala
  11. Orkambi
  12. Praluent
  13. Praxbind
  14. Strensiq
  15. Unituxin
  16. Xuriden

Fast Track (31%)

  1. Avycaz
  2. Corlanor
  3. Cotellic
  4. Daklinza
  5. Darzalex
  6. Entresto
  7. Genvoya
  8. Kanuma
  9. Lonsurf
  10. Orkambi
  11. Portrazza
  12. Strensiq
  13. Tagrisso
  14. Viberzi

Breakthrough (22%)

  1. Alecensa
  2. Darzalex
  3. Empliciti
  4. Ibrance
  5. Kanuma
  6. Orkambi
  7. Praxbind
  8. Strensiq
  9. Tagrisso
  10. Xuriden

Priority Review (53%)

  1. Alecensa
  2. Avycaz
  3. Bridion
  4. Cholbam
  5. Corlanor
  6. Cotellic
  7. Cresemba
  8. Daklinza
  9. Darzalex
  10. Empliciti
  11. Entresto
  12. Farydak
  13. Ibrance
  14. Kanuma
  15. Lenvima
  16. Ninlaro
  17. Orkambi
  18. Praxbind
  19. Strensiq
  20. Tagrisso
  21. Unituxin
  22. Viberzi
  23. Xuriden
  24. Yondelis

Accelerated Approval (13%)

  1. Alecensa
  2. Darzalex
  3. Farydak
  4. Ibrance
  5. Tagrisso
  6. Praxbind

Download the Report in PDF

Download “2015 FDA CDER Novel Drug Approvals” UCM485053.pdf – Downloaded 153 times – 15 MB

Last Updated: 2016-02-03

FDA CDER Approved 45 Novel Drugs in 2015