When was onfi approved by fda

Send the page " " to a friend, relative, colleague or yourself. We do not record any personal information entered above. FDA warns of serious skin reactions with the anti-seizure drug Onfi clobazam and has approved label changes. FDA intends to update this sheet when additional information or analyses become available.

The U. Clobazam Tablets are a benzodiazepine indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome LGS in patients aged 2 years and older.

Studies have shown that clobazam can decrease the frequency of seizures in people with refractory or uncontrolled seizures, but does not completely control them. The dose of clobazam used was important in those studies, according to the Epilepsy Foundation.

People who were given the recommended higher dose had greater improvement in seizures than people who were given a lower dose of clobazam. Maple Grove, Minn.

Princeton, N. Ahmedabad, India; Oct. The pre-dosing baseline mean weekly drop seizure frequency was 98, , 61 and for the placebo, low-, medium- and high-dose groups, respectively.

This effect appeared to be dose dependent. Study 2 This randomized, double-blind comparison study enrolled 68 subjects and evaluated high- and low-dose Onfi. Lundbeck Takeda Pharmaceuticals U.