Biovail Receives Approvable Letter for Cardizem XL.Business Editors, Health & Medical Writers TORONTO--(BW HealthWire)--June 17, 2002 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 that it has received an Approvable Letter from the United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. (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. ) for Cardizem(R) XL (diltiazem HCL extended release tablets), a novel medication for the treatment of hypertension. The New Drug Application was submitted in August 2001. In the Cardizem(R) XL Approvable Letter, the FDA states that it has reviewed the application and that it is approvable, subject to the completion of labeling matters and the submission and review of requested information. In a clinical study comparing Cardizem(R) XL administered at night versus Cardizem(R) XL administered in the morning, nighttime administration resulted in statistically significant and clinically meaningful reductions in diastolic Diastolic The phase of blood circulation in which the heart's pumping chambers (ventricles) are being filled with blood. During this phase, the ventricles are at their most relaxed, and the pressure against the walls of the arteries is at its lowest. and systolic blood pressure Systolic blood pressure Blood pressure when the heart contracts (beats). Mentioned in: Hypertension between the hours of 6 a.m. and 12 noon. Eugene Melnyk, Chairman of the Board and Chief Executive Officer commented, "Biovail is very pleased that the FDA has issued an Approvable Letter for Cardizem(R) XL and we look forward to working closely with the Agency to finalize this process over the coming months. Our sales force expansion program, promotional campaign activities, Phase IV clinical initiatives and other preparations are currently underway to support a launch of this product later this year. We believe the availability of Cardizem(R) XL can provide an important new option for health care practitioners in the treatment of hypertension." 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" 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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