WOODCLIFF LAKE, N.J., Feb. 13 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. (NYSE: BRL) and Women's Capital Corporation (WCC) today said that the U.S. Food and Drug Administration (FDA) has extended the original 10-month Prescription Drug User Fee Act (PDUFA) deadline for completion of its review of the Plan B(R) Supplemental New Drug Application (sNDA). Barr and WCC are seeking approval to market the Plan B emergency contraceptive Over-The-Counter (OTC) without a prescription. The PDUFA extension will permit the FDA to complete its review of the application, including additional data on adolescent use that was submitted by Barr and WCC in support of the application.

Based on its ongoing dialogue with FDA, Barr indicated that it is expecting a decision regarding OTC status for the Plan B emergency contraceptive within 90 days of the original February 20, 2004 PDFUA date. The Plan B emergency contraceptive is currently available by prescription only.

"We will continue to work closely with the Agency to assist in the timely completion of the review and we are committed to providing any additional data that they may need to reach their decision," said Bruce L. Downey, Barr's Chairman and CEO. "We believe that availability of the Plan B emergency contraceptive as an OTC product meets a significant unmet medical need, and that OTC status will remove barriers that currently delay the timely availability of Plan B for women who have had unprotected sexual intercourse or experienced a contraceptive failure."

On December 16, 2003 two FDA Advisory Committees recommended by a vote of 23 to 4 that the FDA approve the request to change the status of Plan B emergency contraceptive from prescription only to OTC.

Taken within 72 hours of unprotected intercourse, Plan B(R) 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 most 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.

Emergency contraception is currently available in 101 countries, 33 of which do not require a prescription. Emergency contraception is currently available in a limited number of pharmacies in five U.S. states (Alaska, California, Hawaii, New Mexico and Washington) without an advance prescription from a physician or healthcare provider.

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, Women's Capital Corporation

In October 2003, Barr announced that it had signed a letter of intent to acquire the emergency oral contraceptive, Plan B, and certain other assets and liabilities of the Women's Capital Corporation (WCC), a Washington, DC-based privately held company. Financial terms of the prospective acquisition were not disclosed. Barr and WCC expect to complete the transaction by February 20, 2004.

WCC was organized in 1997 to develop and market reproductive health products of critical importance to women.

Barr Pharmaceuticals, Inc. and its subsidiaries are engaged in the development, manufacture and marketing of generic and proprietary pharmaceuticals.

Forward-Looking Statements

The following press release contains a number of forward-looking statements. To the extent that any statements made in this press release contain information that is not historical, these statements are essentially forward-looking. Forward-looking statements can be identified by their use of words such as "expects," "plans," "will," "may," "anticipates," "believes," "should," "intends," "estimates" and other words of similar meaning. These statements are subject to risks and uncertainties that cannot be predicted or quantified and, consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include: 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 difficulty of predicting the timing of U.S. Food and Drug Administration, or FDA, approvals; court and FDA decisions on exclusivity periods; the ability of competitors to extend exclusivity periods for their products; the success of our product development activities; 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; the ability to develop and launch new products on a timely basis; the availability of raw materials; the availability of any product we purchase and sell as a distributor; our mix of product sales between manufactured products, which typically have higher margins, and distributed products, which typically have lower margins, during any given period; 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 new enterprise resource planning systems; fluctuations in operating results, including the effects on such results from spending for research and development, sales and marketing activities and patent challenge activities; and other risks detailed from time to time in our filings with the Securities and Exchange Commission.

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