FDA grants exclusivity extension for J&J's Topamax

7/25/2008

TITUSVILLE, N.J. The Food and Drug Administration has granted Johnson & Johnson unit Ortho-McNeil Neurologics exclusivity for Topamax for use in children, Ortho-McNeil announced Thursday.

The decision was based on studies in response to an FDA written request for investigating use of the drug in patients aged 1 month to 2 years with partial onset seizures.

The drug, known generically as topiramate, is normally used to treat seizures in patients aged 10 and older. It had sales of $2.5 billion in 2007, according to J&J financial data.

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