IMPAX Receives Tentative FDA Approval for Generic Rilutek; IMPAX's Fourth Tentative ANDA Approval This Year.Business Editors & Health/Medical Writers HAYWARD, Calif.--(BW HealthWire)--July 22, 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 Rilutek(R) (Riluzole 50mg) tablets. Aventis Pharmaceutical Products, Inc. markets Rilutek(R) for the treatment of amyotrophic lateral sclerosis amyotrophic lateral sclerosis (ALS) (ā'mīətrōf`ik, sklĭrō`sĭs) or motor neuron disease, (ALS Als (äls), Ger. Alsen, island, 121 sq mi (313 sq km), Sønderjylland co., S Denmark, in the Lille Bælt, separated from the mainland by the narrow Alensund. ), also known as Lou Gehrig's disease Lou Geh·rig's disease n. See amyotrophic lateral sclerosis. . According to IMS Health, U.S. sales of Rilutek were $35 million for the 12 months ended March 31, 2002. Final FDA approval is contingent upon the expiration of Orphan Drug Exclusivity on December 12, 2002, resolution of the patent 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. that IMPAX has initiated against Aventis regarding a patent recently listed by Aventis in the FDA "Orange Book," as well as FDA's evaluation of any new information subsequent to this tentative approval. "This is our fourth ANDA tentative approval this year, and we are pleased with the progress we are making in our development and commercialization strategy," 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. of IMPAX Laboratories. "The development of our generic version of Rilutek(R) is consistent with our strategy to develop niche products we believe will have limited competition. Upon final approval, we anticipate that our Global Pharmaceuticals division will market the product." IMPAX currently has 17 ANDA filings pending at the FDA that address more than $9 billion in U.S. branded product sales. Ten of these filings were made under Paragraph IV of the Hatch-Waxman Amendments and four of these 17 ANDAs now have received tentative approval from the 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" 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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