FDAnews Drug Daily Bulletin

FDA WILL NOT REQUIRE ADDITIONAL DATA TO APPROVE SEASONIQUE

March 28, 2006
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Barr Pharmaceuticals' subsidiary Duramed Pharmaceuticals will not have to provide additional clinical data to the FDA before the agency can approve Duramed's experimental contraceptive Seasonique, Barr said recently.

The oral contraceptive is designed to reduce menstrual bleeding from monthly to four times per year.

In August 2005, the FDA issued an approvable letter for Seasonique -- the follow-on product of Barr's oral contraceptive Seasonale (levonorgestrel/ethinyl estradiol), which has been on the market since November 2003 -- and requested additional data on the product. Seasonique is similar to Seasonale, except that it uses a 0.01-mg dose of estrogen in place of a sugar pill during the menstrual cycle.

The FDA had requested more information about the benefits of replacing the sugar pill with a low-dose estrogen pill, according to a Barr spokeswoman.

"We will continue to work closely with the agency to resolve outstanding issues as quickly as possible, and provide the package, labeling and other information they have requested so that the review and approval of this application proceeds as quickly as possible," said Bruce Downey, Barr's chairman and CEO.