Biovail Files NDA for Fluoxetine Flash Dose Brand.Business Editors & Health/Medical Writers TORONTO--(BW HealthWire)--Oct. 2, 2001 Biovail Corporation (NYSE NYSE See: New York Stock Exchange :BVF)(TSE See Tokyo Stock Exchange. TSE 1. See Tokyo Stock Exchange (TSE). 2. See Toronto Stock Exchange (TSE). :BVF) today announced the filing of a New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) for a FlashDose(R) version of fluoxetine with 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. ). Fluoxetine is a leading Selective Serotonin Reuptake Inhibitor selective serotonin reuptake inhibitor n. SSRI. Selective serotonin reuptake inhibitor (SSRI) A class of antidepressants that work by blocking the reabsorption of serotonin in the brain, raising the levels of (SSRI SSRI selective serotonin reuptake inhibitor. SSRI n. Selective serotonin reuptake inhibitor; a class of drugs that inhibit the reuptake of serotonin in the central nervous system, used to treat depression and other ) and is prescribed for depression, obsessive compulsive disorder Obsessive compulsive disorder (OCD) Disorder characterized by persistent, intrusive, and senseless thoughts (obsessions) or compulsions to perform repetitive behaviors that interfere with normal functioning. Mentioned in: Tourette Syndrome and bulimia, and is marketed under the brand name Prozac by Eli Lilly & Company. Prozac had sales of approximately $2.8 billion for the twelve months ended June 2001. FlashDose(R), Biovail's proprietary oral drug delivery dosage format, represents a novel, convenient method of administration versus traditional tablets/capsules and in certain circumstances, can provide enhancements to the performance of the medication including a reduction in adverse effects. FlashDose(R) tablets dissolve readily in the mouth, are pleasantly flavoured and provided doctors with prescribing flexibility that can be advantageous when addressing the needs of certain patient types. Ease of administration, an important consideration in various health care facility settings (nursing homes, hospitals), is of particular interest to the segment of patients that have difficulty swallowing pills, which is estimated to be approximately 15% of patient populations. Biovail also will be commencing a number of clinical studies to show product differentiation and advantages over the currently marketed fluoxetine products. 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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