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my personal edition > migraine > news
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DGNews
FDA Issues Approvable Letter for Migraine Prophylaxis Indication for Topamax (Topiramate)
RARITAN, NJ -- November 18, 2003 -- Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), a Johnson & Johnson company, announced today that the U.S. Food and Drug Administration (FDA) has issued an approvable letter related to its supplemental New Drug Application for the use of Topamax® (topiramate) Tablets and Topamax® (topiramate capsules) Sprinkle Capsules in adults for the prophylaxis of migraine headaches.
The approvable letter provided proposed labeling as well as a request for additional analyses of safety data. The letter did not request any additional studies, and J&JPRD will respond to the agency soon. J&JPRD submitted the application for migraine prophylaxis to the FDA on December 20, 2002.
Topamax, which is marketed in the U.S. by Ortho-McNeil Pharmaceutical, Inc., also a Johnson & Johnson company, is currently indicated in the United States as adjunctive therapy for adults and children aged 2-16 with partial-onset seizures, primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with Lennox-Gastaut syndrome. Topamax is available under various brand names in more than 95 countries and is marketed outside of the United States by other Johnson & Johnson affiliates. It is currently approved as adjunctive treatment for a variety of seizure types and has been approved in more than 60 countries as monotherapy treatment for epilepsy. Marketing approval for Topamax for migraine prophylaxis is being sought in several countries, and regulatory approval for that use has already been granted in the Philippines, Portugal, Thailand and Mexico.
For more information, read the full U.S. prescribing information, available upon request by calling 1-800-682-6532 or by visiting http://www.Topamax.com or http://www.ortho-mcneil.com. Ortho-McNeil Pharmaceutical, Inc. also markets AXERT® (almotriptan malate), an acute migraine therapy, as well as prescription medicines in other therapeutic categories, including women's health, central nervous system, urology, infectious disease and analgesics.
SOURCE: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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