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