Biovail files ANDA for generic Trental; Represents second ANDA filing for Biovail in 1996.TORONTO--(BUSINESS WIRE)--December 17, 1996--Biovail Corporation International (NYSE NYSE See: New York Stock Exchange , TSE See Tokyo Stock Exchange. TSE 1. See Tokyo Stock Exchange (TSE). 2. See Toronto Stock Exchange (TSE). :BVF BVF Biovail Corporation (stock symbol) BVF Berufsverband der Frauenärzte eV (Muenchen, Germany) BVF Bearing Versus Frequency ) today confirmed that it has submitted an Abbreviated New Drug Application abbreviated new drug application Pharmacology An application made in the US by a pharmaceutical company requesting authority to market a 'new' drug for which both its therapeutic indications and formulation were previously approved by the FDA in another similar ("ANDA ANDA abbr. abbreviated new drug application ") for its controlled release generic version of Trental(R), (pentoxifylline) a medication used for the treatment of peripheral vascular disease Peripheral Vascular Disease Definition Peripheral vascular disease is a narrowing of blood vessels that restricts blood flow. It mostly occurs in the legs, but is sometimes seen in the arms. . Trental sales in North America currently approximate $200 million while sales outside North America represent an additional $150 million. The submission represents the second ANDA filing for Biovail in 1996. The Company's twice-daily generic version of Cardizem SR, used in the treatment of Hypertension, was filed previously in May, 1996. Eugene Melnyk, Chairman of the Board, commented, "These filings reaffirm our commitment to growth in the rapidly expanding controlled release market. The Trental submission represents our second ANDA filing this year and further filings will be announced in the near-term." Biovail Corporation International 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: This release contains forward looking statements that are subject to risks and uncertainties, including, but not limited to, the impact of competitive products and pricing, product demand and market acceptance, new product development, reliance on key strategic alliances, availability of raw materials, the telecommunications 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. CONTACT: Biovail Corporation International Eugene Melnyk Chairman of the Board Bob Podruzny Chief Financial Officer (416) 285-6000 or Investor Relations: Donna Stein/ Dan Durkin/Cindy Hintelmann Press: Michael McMullan Morgen-Walke Associates (212) 850-5600 |
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