Biovail and Intelligent Polymers Confirm Generic Procardia XL Filing.TORONTO--(BW HealthWire)--Feb. 12, 1998--Biovail Corporation International (NYSE NYSE See: New York Stock Exchange :BVF)(TSE:BVF) and Intelligent Polymers Limited (AMEX AMEX See: American Stock Exchange :IXP.U) today announced that the Food and Drug Administration (FDA) has accepted 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) for their generic controlled release version of Procardia XL, a calcium channel blocker calcium channel blocker n. Any of a class of drugs that inhibit movement of calcium ions across a cell membrane, used in the treatment of cardiovascular disorders. for the treatment of hypertension and angina. This once daily brand of Nifedipine nifedipine /ni·fed·i·pine/ (ni-fed´i-pen) a calcium channel blocking agent used as a coronary vasodilator in the treatment of coronary insufficiency and angina pectoris; also used in the treatment of hypertension. is marketed by Pfizer Inc. and represents a generic market opportunity in the U.S. in excess of $800 million. This represents the second ANDA filing accepted by the FDA for Biovail in 1998. Biovail currently has six controlled-release generic products, including the Procardia XL filing, awaiting approval by the FDA representing brand sales in the U.S. in excess of $2.2 billion. 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 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 companies' filings with the Securities and Exchange Commission. CONTACT: Biovail Corporation International Eugene Melnyk or Bob Podruzny, 416/285-6000 |
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