FDA Grants Pediatric Exclusivity for Ortho-McNeil’s Seizure Drug
Ortho-McNeil Neurologics, a division of Ortho-McNeil-Janssen Pharmaceuticals, has announced that the FDA has granted pediatric exclusivity for Topomax.
The grant was based on studies submitted in response to a written request by the FDA to investigate the use of Topomax in pediatric patients aged one to 24 months with partial onset seizures.
In addition to granting pediatric exclusivity, the FDA is continuing its review of the application to determine the safety and efficacy of Topomax in this patient population. Based on the data submitted, no indication is sought for this age group.
A recent court decision confirmed the validity of the Topomax patent, which is set to expire in September 2008. However, this grant will extend the period of exclusivity through March 2009. Topomax is not approved for use in pediatric patients aged one to 24 months.
Topomax is indicated as initial monotherapy in patients 10 years of age and older with partial onset seizures or generalized tonic-clonic seizures. It also is indicated 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.