Biovail Announces Filing of Three ANDA's; Generic Versions of Adalat CC 90mg, Procardia XL 90mg and Tegretol 400mg.Business Editors, Health/Medical Writers TORONTO--(BW HealthWire)--Jan. 3, 2001 Biovail Corporation (NYSE NYSE See: New York Stock Exchange :BVF BVF Biovail Corporation (stock symbol) BVF Berufsverband der Frauenärzte eV (Muenchen, Germany) BVF Bearing Versus Frequency )(TSE See Tokyo Stock Exchange. TSE 1. See Tokyo Stock Exchange (TSE). 2. See Toronto Stock Exchange (TSE). :BVF.) announced today it has filed with the Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) Abbreviated New Drug Applications (ANDA ANDA abbr. abbreviated new drug application ) for its generic controlled-release versions of Adalat CC 90mg, Procardia XL 90mg and Tegretol 400mg. Adalat CC is sold by the Bayer Corporation in the United States and is indicated for the treatment of hypertension. Procardia XL is sold by Pfizer Inc. in the United States and is indicated for the treatment of hypertension and angina. Tegretol is sold by Novartis Pharmaceutical Corporation in the United States and is indicated for the treatment of epilepsy. Combined, these filings represent in excess of $220 million of brand sales based on the twelve-month period ended September 2000. Biovail, through its marketing partner Teva Pharmaceuticals, is currently marketing generic versions of Adalat CC (30mg and 60mg) and Procardia XL (60mg) dosage strengths. The total Adalat CC and Procardia XL brand sales value, including all strengths, is in excess of $800 million. Biovail Corporation is an international full-service pharmaceutical company, engaged in the formulation, clinical testing, registration, manufacture, sale and promotion of pharmaceutical products utilizing advanced drug delivery technologies. "Safe Harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. " statement under the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. To the extent any statements made in this release contain information that is not historical, these statements are essentially forward looking and are subject to risks and uncertainties, including the difficulty of predicting FDA approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials, the regulatory environment, fluctuations in operating results and other risks detailed from time to time in the company's filings with the Securities and Exchange Commission. |
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