Health Canada Approves Paladin’s Seasonale

Paladin Labs announced that it has obtained Health Canada’s approval for Seasonale, the first extended-cycle oral contraceptive available in Canada.

According to Paladin, Seasonale (levonorgestrel and ethinyl estradiol 0.15-/0.03-mg tablets) allows women to have four periods per year.

The company said Seasonale is a 91-day regimen taken daily as 84 active tablets, followed by seven inactive tablets, during which time a woman would have her period. By contrast, oral contraceptive products currently on the market are based on a 28-day regimen, with 21 active pills and seven inactive tablets, the company added.

The FDA approved Seasonale in 2003, and studies have shown no increased health risks with the medication compared with traditional birth control pills, the company said.