Barr gets closer to approval of Seasonique extended-cycle oral contraceptive

By Elaine Rigoli

Tampa, Fla., March 17 - Barr Pharmaceuticals, Inc. has been informed by the Food and Drug Administration that additional clinical data will not be required to support the approval of Duramed Pharmaceuticals, Inc.'s New Drug Application for Seasonique (levonorgestrel/ethinyl estradiol tablets 0.15 mg/0.03 mg and ethinyl estradiol tablets 0.01 mg) extended-cycle oral contraceptive.

Barr said it will continue to work with the FDA to resolve outstanding issues including product labeling and post-marketing commitments, according to a company news release.

In August, the FDA issued an approvable letter that requested additional data to support Seasonique's regimen of 84 days of combination therapy, followed by seven days of unopposed estrogen, which reduces the number of menstrual cycles a patient has to four per year.

Barr said it is committed to the extended-cycle oral contraceptive category it created with the launch of the Seasonale extended-cycle oral contraceptive in 2003.

More than 1.6 million prescriptions have been written for Seasonale since its launch, according to the release.

Barr, based in Woodcliff Lake, N.J., is a holding company whose principal subsidiaries, Barr Laboratories and Duramed Pharmaceuticals, develop, manufacture and market generic and proprietary pharmaceuticals.

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