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
58 events · 2013
Dec 26
2013
label expansion
Dec 13
2013
Dec 13
2013
FDA approvalOrphan drug
Dec 12
2013
label expansion
Nov 22
2013
FDA approvalOrphan drug
Adenocarcinoma of the gallbladder and extrahepatic biliary tract· Bayer HealthCare Pharmaceuticals, Inc.
Nov 19
2013
label expansion
· Apotex Corp· ANDA071196
Nov 1
2013
FDA approvalOrphan drug
T-cell prolymphocytic leukemia· Genentech Inc., a member of the Roche Group
Oct 26
2013
label expansion
Oct 26
2013
label expansion
Oct 17
2013
label expansion
· Prasco Laboratories· NDA022580
Oct 8
2013
Sep 30
2013
label expansion
Sep 27
2013
Sep 26
2013
label expansion
Sep 24
2013
label expansion
· Prasco Laboratories· NDA022580
Sep 24
2013
label expansion
Sep 6
2013
FDA approvalOrphan drug
Familial atypical multiple mole melanoma syndrome· Abraxis BioScience, LLC
Aug 30
2013
label expansion
· Onesource Specialty Pharma Limited· ANDA078244
Aug 27
2013
label expansion
· Macleods Pharmaceuticals Limited· ANDA202289
Jul 30
2013
label expansion
Jul 25
2013
label expansion
Jun 12
2013
label expansion
Jun 3
2013
May 29
2013
FDA approval
May 29
2013
FDA approval
May 10
2013
FDA approvalOrphan drug
Acquired aneurysmal subarachnoid hemorrhage· Arbor Pharmaceuticals, Inc.
May 3
2013
label expansion
May 3
2013
label expansion
May 2
2013
Apr 30
2013
label expansion
Apr 29
2013
FDA approvalOrphan drug
Apr 16
2013
label expansion
· Prasco Laboratories· NDA022580
Mar 28
2013
FDA approval
· Neos Therapeutics, LP· NDA022556
Mar 19
2013
label expansion
· Prasco Laboratories· NDA022580
Feb 28
2013
FDA approval
Feb 27
2013
label expansion
Feb 21
2013
label expansion
· Hikma Pharmaceuticals USA Inc.· ANDA065406
Feb 5
2013
Jan 7
2013
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.