WOODCLIFF LAKE, N.J., Aug. 24 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. (NYSE: BRL - News) today said that the U.S. Food and Drug Administration (FDA) has approved the Supplemental New Drug Application (sNDA) filed by Barr’s wholly-owned subsidiary, Duramed Pharmaceuticals, Inc., to market the Plan B® (levonorgestrel) emergency contraceptive Over-The-Counter (OTC) without a prescription. In approving the sNDA, FDA granted OTC status for consumers 18 years of age and older, while maintaining the prescription status for women 17 and younger. The Company’s Plan B OTC product and the prescription product will be marketed as a single package, which will allow for a prescription label to be adhered to the package when dispensed to women age 17 and younger. Because Plan B will still remain a prescription product for women 17 and younger, it will be sold in retail pharmacy outlets from behind the counter. Duramed plans to introduce the dual status Rx/OTC version of the product before the end of the calendar year.
As part of the Plan B OTC approval, the Company has reached an agreement with FDA on its CARE(SM) (Convenient Access, Responsible Education) Program that supports efforts to ensure that Plan B is used responsibly and appropriately. The CARE program is designed to limit the availability of Plan B only to pharmacies and clinics with professional healthcare supervision, to educate healthcare professionals and consumers within the target age groups regarding the availability and responsible use of Plan B, and to monitor the effectiveness of the program. In addition, the Company intends to work closely with retail pharmacies and drug wholesalers to ensure that they understand and follow the FDA’s prescription age requirement for the dispensing of the product.
“While we still feel that Plan B should be available to a broader age group without a prescription, we are pleased that the Agency has determined that Plan B is safe and effective for use by those 18 years of age and older as an over-the-counter product,” said Bruce L. Downey, Barr’s Chairman and CEO. “Although Plan B will continue to be available to all women of child- bearing age, we believe making Plan B available without a prescription to those 18 and older will ensure that millions of women have more timely access to an emergency oral contraceptive following unprotected sexual intercourse or a contraceptive failure. We intend to work with healthcare providers, pharmacists and patients to educate them about the availability of this product. We will also continue our efforts with the FDA to reduce the age restriction on the OTC use of Plan B.”
Taken within 72 hours of unprotected intercourse, Plan B has been shown to reduce the risk of pregnancy by 89 percent after a single act of unprotected sex. Effectiveness declines as the interval between intercourse and the start of treatment increases. Plan B is more effective when taken in the first 24 hours after intercourse. The decline in efficacy from a delay in treatment is why a broad range of health professionals believe that barriers to more timely access to Plan B should be removed, including making the product broadly available without prescription.
There are nearly three million unintended pregnancies each year in the United States. Unintended pregnancy is a major public health issue, affecting women in all reproductive age groups and socio-economic backgrounds. Plan B has been well-studied and shown to reduce the pregnancy rate, after a single incident of unprotected intercourse, from 8% to 1%, an 89% reduction. Plan B should not be used as routine contraception and does not protect against HIV/AIDS and sexually transmitted diseases (STDs).
Emergency contraception is currently available through pharmacy access programs in some pharmacies in nine U.S. states (Alaska, California, Hawaii, Maine, Massachusetts, New Hampshire, New Mexico, Vermont and Washington).
Contraindications for Plan B®
Progestin-only contraceptive pills (POPs) are used as a routine method of birth control over longer periods of time, and are contraindicated in some conditions. It is not known whether these same conditions apply to the Plan B regimen consisting of the emergency use of two progestin pills. POPs are not recommended for use in the following conditions: known or suspected pregnancy; hypersensitivity to any component of the product; and, undiagnosed abnormal genital bleeding.
Barr Pharmaceuticals, Inc. is a holding company whose principal subsidiaries, Barr Laboratories, Inc. and Duramed Pharmaceuticals, Inc., develop, manufacture and market generic and proprietary pharmaceuticals.
Forward-Looking Statements
Except for the historical information contained herein, the statements made in this press release constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements can be identified by their use of words such as “expects,” “plans,” “projects,” “will,” “may,” “anticipates,” “believes,” “should,” “intends,” “estimates” and other words of similar meaning. Because such statements inherently involve risks and uncertainties that cannot be predicted or quantified, actual results may differ materially from those expressed or implied by such forward-looking statements depending upon a number of factors affecting the Company’s business. These factors include, among others: the difficulty in predicting the timing and outcome of legal proceedings, including patent-related matters such as patent challenge settlements and patent infringement cases; the outcome of litigation arising from challenging the validity or non- infringement of patents covering our products; the difficulty of predicting the timing of FDA approvals; court and FDA decisions on exclusivity periods; the ability of competitors to extend exclusivity periods for their products; our ability to complete product development activities in the timeframes and for the costs we expect; market and customer acceptance and demand for our pharmaceutical products; our dependence on revenues from significant customers; reimbursement policies of third party payors; our dependence on revenues from significant products; the use of estimates in the preparation of our financial statements; the impact of competitive products and pricing on products, including the launch of authorized generics; the ability to launch new products in the timeframes we expect; the availability of raw materials; the availability of any product we purchase and sell as a distributor; the regulatory environment; our exposure to product liability and other lawsuits and contingencies; the increasing cost of insurance and the availability of product liability insurance coverage; our timely and successful completion of strategic initiatives, including integrating companies and products we acquire and implementing our new enterprise resource planning system; fluctuations in operating results, including the effects on such results from spending for research and development, sales and marketing activities and patent challenge activities; the inherent uncertainty associated with financial projections; changes in generally accepted accounting principles; and other risks detailed from time-to-time in our filings with the Securities and Exchange Commission, including in our Annual Report on Form 10-K for the fiscal year ended June 30, 2005.
The forward-looking statements contained in this press release speak only as of the date the statement was made. The Company undertakes no obligation (nor does it intend) to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required under applicable law.
Source: Barr Pharmaceuticals, Inc.
