Lundbeck Onfi Gets Dermatological Warning, Bigger Marketing Challenge
This article was originally published in The Pink Sheet Daily
Labeling for Eisai’s Banzel, which also has an indication limited to Lennox-Gastaut syndrome, does not mention Stevens-Johnson syndrome or toxic epidermal necrolysis cited in the Onfi warning.
You may also be interested in...
Clobazam is approved as an add-on to therapy for a particularly severe orphan seizure disorder known as Lennox-Gastaut syndrome.
FDA has made a decision on how to communicate the suicidality risk for anti-epileptic drugs: with the first novel approvals in that class since an advisory committee on the topic, FDA has opted for a Medication Guide over a "black box" warning
Industry also seems supportive of the idea, while Pew touts the power of the power of track-and-trace as a deterrent.