Ortho-McNeil Neurologics, a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., itself a division of Johnson & Johnson, received approval from the FDA for pediatric exclusivity for Topamax for use in patients aged 1 to 24 months with partial onset seizures.
The FDA is continuing its review of the application to determine the safety and efficacy of Topamax in this patient population. Based on the data submitted, no indication is sought for this age group.
A recent court decision extended the drug's period of exclusivity through March 2009. The drug was set to expire in September 2008. Topamax was not approved for use in pediatric patients aged 1 to 24 months.
Topamax is indicated as initial monotherapy in patients 10 years of age and older with partial onset seizures or generalized tonic-clonic seizures, as well as adjunctive therapy for adults and children (aged two and above) with partial onset seizures or generalized tonic-clonic seizures, and in adults and children as adjunctive therapy for the treatment of seizures associated with Lennox-Gastaut syndrome. Topamax is indicated in adults for theprophylaxis of migraine headache.
Magazine
