Biovail Receives FDA Approval for Novel Once Daily Diltiazem Formulation - New Drug Application Optioned to Forest Laboratories.Business Editors, Health/Medical Writers TORONTO--(BW HealthWire)--March 6, 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) today announced that it has received approval from the Food and Drug Administration for its New Drug Application of a novel once daily controlled release formulation of Diltiazem Hcl. Biovail has granted to Forest Laboratories, Inc., Biovail's licensee of Tiazac, an option to acquire the exclusive right to market the product in the United States. Under the terms of the option agreement, Forest has the right to negotiate a license and supply agreement with Biovail containing terms for the supply by Biovail of the product similar to those on which Biovail supplies its Tiazac product to Forest. 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 their 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 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. and TPD TPD Tons Per Day TPD Therapeutic Products Directorate TPD Total and Permanent Disablement (insurance) TPD Temperature Programmed Desorption TPD Temporary Partial Disability (insurance) 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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