After receiving approval for its abbreviated new drug application from the FDA, Mylan has launched a generic version of Meda Pharms' felbamate tablets.
After receiving approval for its abbreviated new drug application from the FDA, Mylan has launched a generic version of Meda Pharms’ felbamate (Felbatol) tablets.
The 400 mg and 600 mg tablets are designed as monotherapy or adjunctive therapy for the treatment of partial seizures, with and without generalization. They may also be used in adults with epilepsy and as adjunctive therapy for treating partial and generalized seizures associated with Lennox-Gastaut syndrome in children.
IMS Health reported that Felbatol tablets had US sales of $53 million for the fiscal year ending on November 30, 2015.
The drug is only recommended for patients who do not respond adequately to alternative treatments and suffer from severe epileptic symptoms.
It should not be used to treat patients with a history of any blood dyscrasias or hepatic dysfunction.
Felbatol can potentially increase the risk of suicidal thoughts and behaviors.
The most common adverse effects associated with the branded version of the drug include sleep problems, headache, and weight loss. However, it may also cause liver failure, which can be fatal.