Treatment Watch
2591 eventsUpdated todayFDA drug approvals, PDUFA decisions, orphan designations, and breakthrough therapy designations for rare diseases — sourced daily from FDA.gov.
All eventsFDA approval (873)PDUFA date (0)Orphan designation (0)Breakthrough therapy (0)Complete response letter (0)Upcoming only·Year:All2015201420132012201120102009200820072006
86 events · 2015
Dec 21
2015
Dec 21
2015
Dec 2
2015
label expansion
· Neos Therapeutics, LP· NDA022556
Nov 30
2015
Nov 24
2015
Nov 20
2015
label expansion
Nov 20
2015
label expansion
Nov 18
2015
Nov 13
2015
FDA approvalOrphan drug
Nov 3
2015
label expansion
Oct 28
2015
FDA approvalOrphan drug
Rare parathyroid disease and phosphocalcic metabolism anomaly· Bristol-Myers Squibb Company
Oct 26
2015
label expansion
· Onesource Specialty Pharma Limited· ANDA078244
Oct 23
2015
FDA approvalOrphan drug
Oct 8
2015
label expansion
Sep 29
2015
Sep 22
2015
label expansion
Sep 18
2015
label expansion
Sep 18
2015
label expansion
Sep 10
2015
label expansion
· Neos Therapeutics, LP· NDA022556
Sep 3
2015
Sep 1
2015
Aug 27
2015
Aug 20
2015
FDA approval
Aug 12
2015
label expansion
· Saptalis Pharmaceuticals, LLC.· ANDA080983
Jul 29
2015
label expansion
Jul 23
2015
Jul 22
2015
Jul 13
2015
Jul 2
2015
FDA approval
Jun 23
2015
label expansion
Jun 16
2015
label expansion
Jun 15
2015
Jun 2
2015
label expansion
· Apotex Corp· ANDA071196
May 22
2015
May 21
2015
May 11
2015
label expansion
May 6
2015
FDA approvalOrphan drug
Envenomization by Bothrops lanceolatus· Rare Disease Therapeutics, Inc.
Apr 17
2015
label expansion
Apr 17
2015
Mar 31
2015
label expansion
Mar 30
2015
FDA approvalOrphan drug
Mar 30
2015
label expansion
Mar 25
2015
label expansion
· Teva Pharmaceuticals USA, Inc.· ANDA077369
Mar 17
2015
FDA approvalOrphan drug
Mar 16
2015
Mar 10
2015
Mar 9
2015
Mar 4
2015
label expansion
Feb 18
2015
Feb 12
2015
label expansion
· Hospira, Inc· ANDA065310
Feb 9
2015
label expansion
· NorthStar Rx LLC· ANDA201090
Jan 30
2015
FDA approval
· Padagis Israel Pharmaceuticals Ltd· ANDA078830
Jan 15
2015
label expansion
· Aurobindo Pharma Limited· ANDA078539
Jan 12
2015
Jan 9
2015
FDA approval
Jan 7
2015
label expansion
Jan 5
2015
Jan 5
2015
label expansion
Not medical advice — always consult your healthcare provider before making treatment decisions.
Data sourced from FDA.gov and openFDA, updated daily. Dates are subject to change. Always verify with FDA.gov for official decisions.