NEW YORK, Jan 11 (Reuters Health) -- The Food and Drug Administration (FDA) has approved a company's application to change the marketing status of a prescription nicotine patch to an over-the-counter (OTC) product to be sold as a store-brand nicotine patch.
Elan's nicotine patch was formerly marketed by Wyeth-Ayerst Laboratories under the trade name ProStep. According to an Elan press release, the OTC product will be marketed by Perrigo of Allegan, Michigan, primarily to the store-brand market.
An FDA spokesperson told Reuters Health that this will allow the patch to be sold as a supermarket or pharmacy retail brand.
An FDA letter dated December 23, 1998 notes that the patch is approved for adult use as an aid to smoking cessation. The Nicotine Transdermal System is manufactured in two doses -- 22 milligrams/day and 11 milligrams/day.
Donal J. Geaney, chairman and CEO of Dublin, Ireland-based Elan, said, "The approval of this (new drug application) provides an opportunity for renewed growth of our nicotine transdermal business and will ensure the availability of an important smoking cessation aid to a broader group of consumers wishing to stop smoking."
Nicotine patches have been available in the US by prescription since 1992, and in OTC forms since 1996. They are used to deliver a dose of nicotine through the skin as part of smoking cessation therapy.
