Biovail Confirms Submission of Response to Wellbutrin XL Approvable Letter.Business Editors/Health/Medical Writers TORONTO--(BUSINESS WIRE)--July 9, 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) confirms that the Company and its partner GlaxoSmithKline responded last week to the Approvable Letter recently issued by 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. ) 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 submission responded to routine matters identified in the Approvable Letter and consequently, final approval of Wellbutrin XL(TM) is expected during the second half of 2003. 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. |
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