Biovail Announces Receipt of an Approvable Letter for Wellbutrin XL.Business Editors/Health/Medical Writers TORONTO--(BUSINESS WIRE)--June 26, 2003 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 ) (TSX TSX Toronto Stock Exchange (TSE before April, 2002) TSX Transfer from Stack Pointer to Index TSX True Space Extension :BVF) announced today that the U.S. 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 issued an Approvable Letter for the once-daily antidepressant Wellbutrin XL(TM) (bupropion hydrochloride extended-release tablets) developed for the treatment of major depressive disorder Major depressive disorder A mood disorder characterized by profound feelings of sadness or despair. Mentioned in: Conduct Disorder major depressive disorder in patients aged 18 and older. The Approvable Letter involves resolution of routine matters and consequently, approval of Wellbutrin XL(TM) is still expected during the second half of 2003. Responses to these routine matters are being prepared expeditiously and are expected to be submitted to the FDA promptly. The National Institute of Mental Health The National Institute of Mental Health (NIMH) is part of the federal government of the United States and the largest research organization in the world specializing in mental illness. estimates that close to 19 million American adults, or 9.5 percent of the population, suffer from a depressive illness in any given one-year period. According to the American Psychiatric Association The American Psychiatric Association (APA) is the main professional organization of psychiatrists and trainee psychiatrists in the United States, and the most influential world-wide. Its some 148,000 members are mainly American but some are international. , depression is one of the most treatable mental illnesses, with most people who receive treatment finding some relief. Biovail licensed the worldwide (excluding Canada) sales and distribution rights to Wellbutrin XL(TM) to GlaxoSmithKline (GSK) in October 2001. Under the terms of the agreements and subject to regulatory approvals, Biovail will manufacture and supply all of GSK's trade and sample supply requirements. Biovail's supply price is based on a percentage of the GSK's net sales of Wellbutrin XL(TM) and Biovail is responsible for the costs to manufacture the product. About Biovail Corporation 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. It is headquartered in Toronto, Canada. For further Biovail investor information, please contact Ken Howling at 905-286-3000 or send inquiries to ir@biovail.com. "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. |
|
||||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion