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FDA Grants Pediatric Exclusivity for TOPAMAX(R), Extending the Marketing Exclusivity by Six Months
Date:7/24/2008

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 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.

A recent court decision confirmed the validity of the TOPAMAX patent, which is set to expire in September 2008. However, this grant will extend the period of exclusivity through March 2009. TOPAMAX is not approved for use in pediatric patients aged 1 to 24 months.

TOPAMAX(R) is indicated as initial monotherapy in patients 10 years of age and older with partial onset seizures or generalized tonic-clonic seizures. It also is indicated as adjunctive therapy for adults and children (aged two and above) with partial onset seizures or generalized tonic-clonic seizures, and in adults and children as adjunctive therapy for the treatment of seizures associated with Lennox-Gastaut syndrome. TOPAMAX(R) is indicated in adults for the prophylaxis of migraine headache.

Important Safety Information: Serious risks associated with TOPAMAX include lowered bicarbonate levels in the blood resulting in an increase in the acidity of the blood (metabolic acidosis). Symptoms could include hyperventilation (rapid, deep breathing), tiredness, loss of appetite, irregular heartbeat or changes in the level of alertness. Call your doctor immediately if you get these symptoms. Your doctor may want to do simple blood tests. Chronic, untreated metabolic acidosis may increase the risk for kidney ston
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SOURCE Ortho-McNeil-Janssen Pharmaceuticals, Inc.
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