Biovail's Generic Procardia XL Tentatively Approved by the FDA.Business Editors TORONTO--(BW HealthWire)--July 25, 2000 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 that 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. ) has granted tentative approval of its generic once daily controlled release version of Procardia XL. Procardia XL is a nifedipine nifedipine /ni·fed·i·pine/ (ni-fed´i-pen) a calcium channel blocking agent used as a coronary vasodilator in the treatment of coronary insufficiency and angina pectoris; also used in the treatment of hypertension. product indicated for the treatment of hypertension and angina and had brand sales in excess of $522 million for the twelve months ended December 1999. Biovail anticipates launching generic Procardia XL through its US marketing partner Teva Pharmaceuticals Industries, Limited after the expiry of 30 months from date of Paragraph IV certification. The launch of generic Procardia XL will represent Biovail's fourth product launch in less than twelve months. Biovail Corporation is an international full-service pharmaceutical company, engaged in the formulation, clinical testing, registration and manufacture of drug products utilizing advanced drug delivery technologies. "Safe Harbor" 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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