MADISON, N.J., June 28 /PRNewswire-FirstCall/ -- Wyeth (NYSE: WYE - News) announced today that the U.S. Food and Drug Administration (FDA) issued an approvable letter for Lybrel(TM) (90 microgram levonorgestrel/20 mircrogram ethinyl estradiol tablets), a low dose, continuous, non-cyclic combination oral contraceptive. In response to the approvable letter, Wyeth will submit additional stability data regarding the Lybrel manufacturing method and additional analyses of submitted clinical data. The agency also indicated that it plans to convene a public meeting of contraceptive experts this year to discuss the clinical aspects of Lybrel. The anticipated topics include a review of the U.S. Pearl Index [a calculation of the pregnancy rates among study participants], bleeding patterns, and the discontinuation rate among women in the study.
"Wyeth is confident that we can address the questions raised by the FDA, and we expect to move toward the launch of Lybrel," says Gary Stiles, M.D., Executive Vice President and Chief Medical Officer, Wyeth Pharmaceuticals.
Wyeth is seeking market approval for Lybrel, an investigational low dose combination oral contraceptive for the prevention of pregnancy in women who elect to use oral contraception and who have no known contraindications for this method of contraception. If approved, this investigational product will contain a low daily dose of ethinyl estradiol and levonorgestrel, a well- studied combination. It is expected to be the only combination oral contraceptive approved with this regimen designed to be taken daily, 365 days a year, without a placebo phase or pill-free interval.
About Oral Contraceptives
Oral contraceptives are not for every woman. Most related side effects are not serious. Serious side effects occur infrequently. Serious risks of all birth control pills that can be life threatening include blood clots, stroke, and heart attack. These risks are increased in women who smoke cigarettes, especially women over 35. Women who use oral contraceptives should not smoke. Some women should not use oral contraceptives, especially women who have had a heart attack, stroke, blood clots, certain cancers or liver diseases, unexplained vaginal bleeding and those who are or may become pregnant. Oral contraceptives do not protect against HIV infection (AIDS) or sexually transmitted diseases.
Wyeth is one of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing, and marketing of pharmaceuticals, vaccines, biotechnology products and nonprescription medicines that improve the quality of life for people worldwide. The Company's major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare, and Fort Dodge Animal Health. The statements in this press release that are not historical facts are forward-looking statements based on current expectations of future events and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include risks associated with the inherent uncertainty of the timing and success of product research, development and commercialization (including with respect to our pipeline products), drug pricing and payment for our products by government and third- party payors, manufacturing, data generated on the safety and efficacy of our products, economic conditions including interest and currency exchange rate fluctuations, changes in generally accepted accounting principles, the impact of competitive or generic products, trade buying patterns, global business operations, product liability and other types of litigation, the impact of legislation and regulatory compliance, intellectual property rights, strategic relationships with third parties, environmental liabilities, and other risks and uncertainties, including those detailed from time to time in our periodic reports filed with the Securities and Exchange Commission, including our current reports on Form 8-K, quarterly reports on Form 10-Q and annual report on Form 10-K, particularly the discussion under the caption "Item 1A, Risk Factors." We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.