IMPAX Receives FDA Tentative Approval of Fenofibrate ANDA; IMPAX's First Tentative Approval of an ANDA with a Paragraph IV Filing.Business Editors & Medical/Health Writers HAYWARD, Calif.--(BW HealthWire)--Feb. 21, 2002 IMPAX Laboratories, Inc. (Nasdaq:IPXL) today announced 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 granted tentative approval to the Company's 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 a generic version of Tricor(R) (Fenofibrate Capsules), Micronized. Tricor is marketed by Abbott Laboratories, Inc. (NYSE NYSE See: New York Stock Exchange :ABT ABT About ABT Abteilung (German: Department) ABT Abbott Laboratories (stock symbol) ABT American Ballet Theatre ABT Associação Brasileira de Telemarketing ABT Abort ABT Availability Based Tariff ) for the treatment of very high serum triglyceride levels. According to IMS Health, U.S. sales of the capsule form of the prescription lipid-regulating agent were over $235 million in 2001. Abbott has announced the discontinuation of the capsule form and its replacement by a new tablet form. The tentative approval covers Fenofibrate Capsules (Micronized) 67 mg, 134 mg and 200 mg capsules. Final approval is contingent upon the earlier of (1) the settlement of pending patent-infringement litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. brought by Abbott against IMPAX, or (2) the expiration of the 30-month stay process under the Hatch-Waxman Amendments; and the expiration of any generic marketing exclusivity. Final approval is also dependent upon FDA's evaluation of any new information subsequent to this tentative approval. IMPAX Laboratories announced FDA acceptance of the Company's ANDA filing for Fenofibrate in July 2000, and commented on the filing of a lawsuit by Abbott Laboratories alleging patent infringement patent infringement n. the manufacture and/or use of an invention or improvement for which someone else owns a patent issued by the government, without obtaining permission of the owner of the patent by contract, license or waiver. relating to the ANDA in September 2000. "We are delighted to receive this notification for Fenofibrate Capsules (Micronized), our first tentative approval of an ANDA containing a Paragraph IV certification," said Larry Hsu, Ph.D., President and Chief Operating Officer Chief Operating Officer (COO) The officer of a firm responsible for day-to-day management, usually the president or an executive vice-president. . "Upon resolution of the tentative approval provisions, our generic version of Tricor(R) will be marketed in the U.S. by our Global Pharmaceuticals division." IMPAX currently has 15 ANDA filings pending at the FDA that address more than $8 billion in U.S. branded product sales. Nine of these filings were made under Paragraph IV of the Hatch-Waxman Amendments and one of these now has tentative approval from FDA. IMPAX Laboratories, Inc. is a technology based specialty pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and niche generics in addition to the development of branded products. IMPAX markets its generic products through its Global Pharmaceuticals division and intends to market its branded products through the IMPAX Pharmaceuticals division. IMPAX Laboratories is headquartered in Hayward, California, and has a full range of capabilities in its Hayward and Philadelphia facilities. For more information, please visit the Company's Web site at: www.impaxlabs.com. "Safe Harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. " 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 To the extent any statements made in this news 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 filings and 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, uncertainty of patent litigation filed against us, 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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