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Generic Accutane Capsules Approved, Launch Scheduled for May
POMONA, N.Y., April 11 /PRNewswire-FirstCall/ -- Barr Laboratories, Inc. today announced that the U.S. Food & Drug Administration (FDA) has approved its application to manufacture and market a generic version of Roche Pharmaceutical's Accutane® Capsules, 10 mg, 20 mg and 40 mg.
The Company plans to market the product as a generic under the trademark name Claravis™. The Company plans to launch the product in May.
"With the approval of Claravis, the Company demonstrates our ability to successfully develop complex generic products," said Bruce L. Downey, Barr's Chairman and CEO. "We also have established an extensive educational program, including dissemination of educational materials to physicians and pharmacists, a patient and physician education and registry program and establishment of a toll free number and website for both physicians and patients who may have questions regarding use of the product."
The Company plans to promote the product to dermatologists using its sales force that currently markets Trexall™ (Methotrexate Tablets, USP). Barr has implemented a comprehensive education, risk assessment and management program for patients, pharmacists and physicians that includes, but is not limited to, a toll free registration program for prescriber registration and education, a website for healthcare professionals and patients, patient education materials designed to inform patients about the risks associated with use of Claravis, and a pregnancy prevention program. The risk management aspects of the program include pregnancy testing and avoidance, patient awareness and consent to avoid pregnancy, and aware ness of psychoactive disorders prior to and during therapy.
Claravis is indicated for the treatment of severe recalcitrant nodular acne. Because of the significant adverse effects associated with its use, Claravis should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. In addition, for female patients of childbearing potential, Claravis is indicated only for those females who are not pregnant and will not become pregnant.
Claravis will compete in the Accutane marketplace that had total annual sales of approximately $523 million for the most recent twelve months ending January 2003.
Barr Laboratories, Inc. is a specialty pharmaceutical company engaged in the development, manufacture and marketing of generic and proprietary pharmaceuticals.
Safe Harbor Statement: To the extent that any statements made in this report contain information that is not historical, these statements are essentially forward-looking. 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 those relating to 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 past initial patent terms; market and customer acceptance and demand for our pharmaceutical products; reimbursement policies of third party payors; our ability to market our proprietary products; the successful integration of acquired businesses and products into our operations; 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; availability of any product we purchase and sell as a distributor; the regulatory environment; fluctuations in operating results, including spending for research and development, sales and marketing and patent challenge activities; and, other risks detailed from time-to-time in our filings with the Securities and Exchange Commission, or SEC. Forward- looking statements can be identified by the 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 statement. The Company undertakes no obligation to publicly update any forward-looking statements.