Drug Approval Dates

Upcoming PDUFA Dates

April 2019

  • HRTX: PDUFA date under priority review April 30, 2019 – Received CRL
  • NBRV: PDUFA date under priority review April 30, 2019 – Received CRL

May 2019

  • NVS: PDUFA date under priority review May 2019
  • SNY: PDUFA date under priority review May 1, 2019
  • REGN: PDUFA date for sBLA May 13, 2019
  • INCY, NVS: PDUFA date under priority review extended by three months to May 24, 2019
  • REGN: PDUFA date for sBLA May 13, 2019

June 2019

  • AGN: PDUFA date under priority review 2Q 2019
  • PFE: PDUFA date under priority review June 2019
  • MRK:
    • PDUFA date under priority review June 3, 2019
    • PDUFA date under priority review June 10, 2019
  • XERS: PDUFA date June 10, 2018.
  • AGIO: PDUFA date under priority review June 21, 2019
  • AMAG, PTN: PDUFA date extended to June 23, 2019
  • ACER: PDUFA date under priority review June 25, 2019
  • REGN, SNY: PDUFA date under priority review June 26, 2019
  • CELG: PDUFA date under priority review June 27, 2019
  • ALXN: PDUFA date under priority review June 28, 2019.

July 2019

  • KPTI: Awaiting of data from BOSTON trial, late-2019/2020 for approval
  • BHVN: Estimate PDUFA July 26, 2019
  • LLY: Estimated PDUFA July 2019
  • PTCT: PDUFA date July 4, 2019
  • CLVLY: PDUFA date under priority review July 8, 2019
  • MRK: PDUFA date under priority review July 16, 2019
  • CELG: PDUFA date for sNDA July 21, 2019

August 2019

  • KALA: PDUFA date August 15, 2019
  • VNDA: PDUFA date August 16, 2019.
  • RHHBY: PDUFA date under priority review August 18, 2019
  • NBRV: PDUFA date under priority review August 19, 2019
  • ABBV: PDUFA date under priority review estimated at August 19, 2019
  • SRPT: PDUFA date under priority review August 19, 2019
  • SGEN; RHHBY: PDUFA date under priority review August 19, 2019
  • IPCIF:  NDA resubmitted with new PDUFA date of August 28, 2019
  • NKTR: PDUFA date extended three months to August 29, 2019

September 2019

  • CELG; RHHBY: PDUFA date September 2, 2019
  • CELG: PDUFA date September 3, 2019
  • XERS: PDUFA date September 10, 2019
  • ARDX: PDUFA date September 12, 2019
  • AVDL: PDUFA date September 15, 2019
  • MRK: PDUFA date September 20, 2019
  • NVO: PDUFA date September 20, 2019
  • ITCI: PDUFA date September 27, 2019
  • JNJ: PDUFA date September 27, 2019
  • AMRN: PDUFA date September 28, 2019

October 2019

  • GILD: PDUFA date October 4, 2019
  • CLVLY: PDUFA date October 6, 2019
  • PFNX: PDUFA date October 7, 2019
  • JNJ: PDUFA date October 11, 2019
  • RHHBY: PDUFA date October 11, 2019
  • FLXN: PDUFA date October 14, 2019
  • AMGN: PDUFA date October 18, 2019
  • ALXN: PDUFA date October 19, 2019
  • CLSD: PDUFA date October 19, 2019
  • ASRT: PDUFA date October 19, 2019
  • FOMX: PDUFA date October 20, 2019
  • ETON: PDUFA date October 21, 2019
  • MLNT;LGND: PDUFA date October 24, 2019
  • GSK: PDUFA date October 24, 2019
  • ADMP: PDUFA date October 31, 2019

November 2019

  • RDHL: PDUFA date under priority review November 2, 2019
  • RHHBY: PDUFA Date November 4, 2019
  • LPCN: PDUFA date November 9, 2019
  • LLY: Estimated PDUFA date November 13, 2019
  • AGRX: PDUFA date November 16, 2019.
  • AQST: PDUFA date November 30, 2019