PR Newswire - FDA Grants Pediatric Exclusivity for TOPAMAX®, Extending the Marketing Exclusivity by Six Months
Thursday, October 16th, 2008 TITUSVILLE, N.J., July 24 /PRNewswire/ — 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 exclusivi…
