Data from Pharmawand - Curated by EPG Health - Date added 08 February 2019

Incyte announced that the FDA has extended the review period for the supplemental New Drug Application (sNDA) for ruxolitinib (Jakafi) for the treatment of patients with acute graft-versus-host disease (GVHD) who have had an inadequate response to corticosteroids. The new Prescription Drug User Fee Act (PDUFA) target action date is 24 May 2019.

The FDA extended the action date to allow time to review additional data submitted by Incyte in response to the FDA’s information requests. The submission of the additional information has been determined by the FDA to constitute a Major Amendment to the sNDA, resulting in an extension of the PDUFA goal date by three months.

Comments

You will need to login, to leave a comment.

epgonline.org is not monitored for collection of adverse event reports. Any adverse events should be reported to your national reporting agency and/or the manufacturer.

Learning Zones

An epgonline.org Learning Zone (LZ) is an area of the site dedicated to providing detailed self-directed medical education about a disease, condition or procedure.

Transplantation

Transplantation

See information on best practice in solid organ transplantation, and expert discussions on related hot topics.

Fibrinogen Deficiency in Bleeding

Fibrinogen Deficiency in Bleeding

Fibrinogen is important for blood clot formation and breakdown. It is the first coagulant factor to be reduced to critical levels during massive trauma, cardiac surgery and postpartum haemorrhage that involve excessive bleeding. Persistent fibrinogen deficiency can lead to bleeding complications and an increased risk in mortality. This learning zone looks at both congenital and acquired fibrinogen deficiencies including indications and techniques for diagnosis, trigger level for treatment and treatment options.

Chronic Lymphocytic Leukaemia (CLL)

Chronic Lymphocytic Leukaemia (CLL)

Refine your knowledge of chronic lymphocytic leukaemia (CLL) with information on pathophysiology, diagnosis, treatment options and more

+ 1 more

Load more

Related Content