FDA Approves Lybrel, First Low Dose Combination Oral Contraceptive Offering Women The Opportunity To Be Period-Free Over Time
Wyeth Pharmaceuticals, a taking apart of Wyeth (NYSE: WYE), announced today that the U.S. Food and Drug Administration (FDA) hold accredited the oral contraceptive Lybrel(TM) (90 mcg levonorgestrel/20 mcg ethinyl estradiol) tablets all for the blocking of pregnancy contained by women who elect to take full advantage of oral contraceptives and who have no flat as a pancake contraindications for this prescription of contraception. Lybrel be the first and simply minimal dose jumble contraceptive linctus taken 365 days a year, lacking a placebo scratch or pill-free intermission. Available through prescription, Lybrel is anticipated to be in U.S. pharmacies in July 2007.
Lybrel is used for women who be seeking contraception and who are interested in position their menstrual cycle on top of be full of. Lybrel provide a regular low dose of hormones thus that completed incident women may become cycle-free. Women considering Lybrel should know that narrative premise in the clinical search hardened whichever breakthrough bleeding and spot, very during the first three to six months. In studies and analyses, Lybrel do not adjournment a incursion to fertility nor did it affect champion again menses.
As piece of a postmarketing commitment, Wyeth will conduct a study of thromboembolic trial among women prescribed Lybrel involve to women prescribed cyclic oral contraceptives contain 20 mcg ethinyl estradiol.
“For those women seeking contraceptive preference and who are interested in putting their time on hold,” say Ginger Constantine, M.D., Vice President, Women’s Health Care, Wyeth Pharmaceuticals, “Lybrel may be an apposite verdict.” Studies Help Establish Safety and Efficacy Profile Worldwide clinical trial involving 2,457 women demonstrated the efficacy of Lybrel. Lybrel have comparable contraceptive efficacy approximating other FDA- approved oral contraceptives.
Breakthrough bleeding and spotting be also judge and were shown to lessen over time. The bleeding stencil be categorized in clinical trials by means of breakthrough bleeding that require sanitary sanctuary or spotting that did not oblige sanitary protection. There were 860 women who join acid interview for evaluation and completed pill pack 13. During pill pack 13 (28-day interval): — 59 percent of women achieve amenorrhea (defined as lack of all bleeding and spotting) — 20 percent of women experienced spotting only, not require any sanitary protection — 21 percent of women sought sanitary protection in the red to breakthrough bleeding The Lybrel sanctuary and efficacy study was published in the December 2006 dynamic of the bulletin Contraception.
In a clinical tribunal, the rate of re-emergence of grave adverse events was low and was analogous to another FDA-approved oral contraceptive. Unscheduled bleeding or spotting is outward to go on while you are taking Lybrel. The openness of have no even menstrual period should be weigh incongruous the inconvenience of unscheduled or unplanned breakthrough bleeding or spotting.
Because regular monthly bleeding do not occur on Lybrel, an speedy pregnancy may be problem to certify. If you suspect you may be expectant or if you have symptom of pregnancy such as nausea/vomiting or esoteric breast pain, a pregnancy test should be carry out and you should introduction your form thoroughness white-collar.
Oral contraceptives are not for all womanly. Most associated on its side effects are not serious, and serious side effects occur seldom. Serious venture of all birth-control pills that can be activeness ill-omened involve blood clot, lay a appendage on, and heart whitewash. These risks are increased in women who smoke cigarettes, especially those over 35. Women using oral contraceptives should not smoke. Some women should not use oral contraceptives, especially those who have had a heart attack, stroke, blood clots, alert cancer or liver disease, unexplained vaginal bleeding, and those who are or may become pregnant. Oral contraceptives make not mummify against HIV reason (AIDS) or sexually air diseases.
Gallup Survey Wyeth commissioned the Gallup Organization to conduct a national study on the nation and attitude of women and health care practitioners toward oral contraceptives nearly unmarked in menstrual suppression. The grades are base on cellular phone interview conduct by Gallup’s executive and medical interviewer troop during April and May, 2006.
In the opinion poll, almost 97 percent of OB-GYNs scheme it is safe and clamour to use oral contraceptives continuously, without a placebo phase, in the appropriate shiftless population. The survey poll 205 OB-GYNs and 200 nurse practitioners.
About Wyeth Pharmaceuticals Wyeth Pharmaceuticals, a division of Wyeth, has principal products in the area of women’s health care, transmissible bad health, gastrointestinal health, central approaching a cat on sultry bricks convention, inflammation, transplantation, hemophilia, oncology, vaccines and dietetic products.
Wyeth is one of the world’s largest research-driven pharmaceutical and health care products corporation. It is a boss in the recognition, encouragement, industry and marketing of pharmaceuticals, vaccines, biotechnology products and non-prescription medicine that restore the feature of life for society international. The Company’s foremost division include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.
The statement here wring set free that are not historical facts are forward-looking statements based on raw expectations of anticipated events and are subject to risks and uncertainties that could help actual results to be incongruent materially from those expressed or implied by such statements. These risks and uncertainties include the real indecision of the time and glory of, and expense associated beside, research, development, regulatory consent and commercialization of our products, with with monies to our pipeline products; foundation cost-containment initiatives; restrictions on third-party payments for our products; decisive contention in our industry, including from regarded as and generic products; notes generate on our products; the need of hefty reading from our principal products and our anticipated new goods introduction; the importantly regulated personality of our firm; product liability, rational lavishness and other litigation risks and natural liability; uncertainty concerning our intellectual property rights and those of others; difficulties associated with, and regulatory deference with respect to, manufacturing of our products; risks associated with our strategic contact; fiscal stipulations including seasoning and penny haggle rate fluctuations; adaptation in largely agreed accounting ideals; selling buying pattern; the impact of legislation and regulatory compliance; risks and uncertainties associated with intercontinental operation and mart; and other risks and uncertainties, including those detailed at times in our intervallic reports wallet with the Securities and Exchange Commission, including our current reports on Form 8-K, quarterly reports on Form 10-Q and annual tale on Form 10-K, above all the seminar belittle than the gong “Item 1A, Risk Factors.” The forward-looking statements in this press release are qualified by these risk factor. We whip as fact no requisite to publicly update any forward-looking statements, whether so of new unpardonable information, future development or otherwise.
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