The U.S. Food and Drug Administration has granted a six month pediatric exclusivity to Ortho-McNeil-Janssen Pharmaceuticals for its drug Topamax for use in patients aged 1 to 24 months with partial onset seizures.
The extension does not give the drug FDA approval but instead allows the pharmaceutical 6 months to continue to investigate the use of Topamax on this specific segment of patients.
Currently Topamax is approved for use with patients 10 years of age and older with partial onset seizures or generalized tonic-clonic seizures. It is also indicated in adults for the treatment of migraine headaches.
Recent research may have found a link between the use of Topamax and birth defects and recently, along with other epilepsy drugs, narrowly escaped being required to have a black box warning by the FDA.
[Source: PRNewsWire]
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It is also indicated in adults for the treatment of migraine headaches.
Posted by: 花蓮民宿 | January 11, 2009 3:00 AM | Permalink to Comment