FDA Grants Pediatric Exclusivity for Topamax

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By: Tim Wright

Editor-in-Chief, Contract Pharma

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 de...

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