Ortho-McNeil Neurologics, a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., announced today that the U.S. Food and Drug Administration (FDA) has granted pediatric exclusivity for TOPAMAX(R) (topiramate), based on studies submitted in response to a Written Request by the FDA to investigate the use of TOPAMAX in pediatric patients aged 1 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 TOPAMAX in this patient population. Based on the data submitted, no indication is sought for this age group.
The details can be read here.
1 comment:
I can't wait for Topamax to be released as a generic I have 2 children one for migraines the other for seizures the doctor is going to let the child with migraines take the generic and we will wait before checking on the child with epilepsy this medication works great but it is very expensive I work and have insurance but the amount out of pocket for my 2 children is over 200.00 a month and no one can help me paying for this we do without a lot so they can have there meds I am just glad I may be able to afford meds better now.
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