Bayer AG´s New Contraceptive Pill Qlaira Wins Approval from Dutch Regulators (Update 2)Bayer AG announced it had been granted approval for Qlaira, a new contraceptive pill to add to Bayer´s successful group of existing birth control pills obtained as part of the giant German company´s takeover of Schering.
10-16-2008 |
10:20 hs.
Author: Cate Kirby
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Bayer AG announced it submitted to Dutch regulators and won approval for marketing of its contraceptive pill Qlaira, in what is called a decentralized approval process. As part of the procedure, the clearance given by the Dutch regulating agency would be recognized and converted into national law by the other EU member states in coming weeks. Bayer said it is also developing Qlaira for the treatment of an excessive menstrual bleeding condition known as dysfunctional uterine bleeding, or DUB, for which there is currently no approved treatment. The company, which said the pill would likely be on the markets by 2009, estimates that Qlaira could generate sales of up to 500 million euros ($ 683.1 million dollars) per year. Bayer plans to seek U.S. approval next year. Bayer has said that the combination of estradiol, or body-identical estrogen, and the progestin dienogest used in Qlaira put less of a strain on the liver and the body's metabolism than conventional pills.
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