Extended-cycle birth control pill wins FDA approval
WASHINGTON — An extended-cycle birth control pill that limits women to just four menstrual periods a year received federal approval Thursday.
The Food and Drug Administration approved Seasonique, spokeswoman Susan Cruzan said. The pill is made by Duramed Pharmaceuticals Inc., a unit of Barr Pharmaceuticals Inc. of Woodcliff Lake, N.J.
The pill is similar to the company’s Seasonale, which was approved by the FDA in 2003. Both include a standard birth control pill that’s taken for 84 days.
With Seasonique, however, women then take low-dose estrogen pills for seven days, instead of the sugar pills that accompany Seasonale and most other birth control pills.
Keeping women on estrogen instead of dummy pills during the menstrual cycle limits hormonal fluctuation, bloating and breakthrough bleeding, according to the company.
Winning approval for Seasonique may prove key for Barr, since a generic version of Seasonale could come on the market later this year, undercutting sales of that product.
Seasonique should be available for prescription sales in July, the company said.
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UN envoy meets Sudanese president to push for UN peacekeepers in Darfur
KHARTOUM, Sudan — Sudan said Thursday it would permit the U.N. to lay the groundwork for possible deployment of a peacekeeping force in Darfur, but cautioned that the world body’s role would be smaller than some Security Council members want.
U.N. envoy Lakhdar Brahimi told a press conference that the acceptance of a U.N. team was an "important step” in cooperation between the world body and Sudan, which had previously barred the team from the troubled western region.
The U.N. Security Council in a resolution last week gave Khartoum one week to accept it as the U.N. prepared to take over peacekeeping in Darfur from an under-equipped African Union mission that has failed to end a three-year conflict.
"This joint mission of the United Nations and the African Union will start with detailed and wide-ranging consultations in Khartoum,” Brahimi said, announcing that the team would arrive in the coming days. "It will then proceed to Darfur to assess the additional needs of (the African Union peacekeeping force), which must be immediately strengthened.”
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