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.
Seasonique is expected to cost about a dollar a pill, the same as Seasonale.
Researchers trace HIV to wild chimps in Cameroon
WASHINGTON - Researchers have confirmed that the virus that causes human AIDS originated in wild chimpanzees in Cameroon.
Scientists have long known that captive chimps carry their own version of HIV, called SIV or simian immunodeficiency virus. But it was difficult to find in wild chimpanzees, complicating efforts to pin down just how the virus could have made the jump from animal to man.
Fitting that final piece of the puzzle required seven years of research just to develop tests to genetically trace the virus in living wild chimps without hurting the endangered species. Then trackers had to plunge through the dense forests of West Africa and scrape up fresh ape feces, more than 1,300 samples in all.
Until now, "no one was able to look. No one had the tools," said Dr. Beatrice Hahn of the University of Alabama at Birmingham. She led the team of international researchers that reported the success in today's edition of the journal Science.
Hahn's team tested chimp feces for SIV antibodies, finding them in a subspecies called Pan troglodytes troglodytes in southern Cameroon.
The first human known to be infected with HIV was a man from Kinshasa in the nearby country of Congo. He had his blood stored in 1959 as part of a medical study, decades before scientists knew the AIDS virus existed.
Presumably, someone was bitten by a chimp or was cut while butchering one and became infected. That person passed it to someone else.
Formerly banned drug okayed to treat cancer
WASHINGTON - Thalidomide received federal approval Thursday for treatment of bone marrow cancer, marking the further rehabilitation of a drug originally banned more than 40 years ago after it caused thousands of birth defects.
The Food and Drug Administration approved the drug for the treatment of newly diagnosed multiple myeloma, agency spokeswoman Laura Alvey said. Multiple myeloma refers to cancers that affect cells in the bone marrow that are key to fighting infection.
Thalidomide, made by Celgene Corp. of Summit, N.J., and sold as Thalomid, is to be used in conjunction with dexamethasone, a standard chemotherapy treatment.
Thalidomide was banned worldwide in 1962. In 1998, it received FDA approval for the treatment of leprosy. It is now marketed under a restricted distribution program and bears severe warnings cautioning patients of the risk of birth defects. Its new labeling also warns of the risk of blood clots in the legs and lungs in multiple myeloma patients who take it with dexamethasone.
