Andrx Granted FDA Tentative Approval for Generic Claritin-D24.Business Editors/Health & Medical Writers Andrx Corporation (Nasdaq:ADRX ADRX Andrx Corporation (stock symbol) ) today announced that the United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. (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 tentatively approved the marketing of its 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 loratadine and pseudoephedrine sulfate, USP USP - unique sales point extended release tablets, which is bioequivalent bi·o·e·quiv·a·lent n. A value indicating the rate at which a substance enters the bloodstream and becomes available to the body. to Schering-Plough Corporation's Claritin-D(R) 24 Hour product. Andrx's generic version of this product employs Andrx's patent-pending MACS (modified antihistamine-decongestants combination system) technology. Claritin-D 24 is used to provide relief of symptoms of seasonal allergic rhinitis seasonal allergic rhinitis, n See hay fever. seasonal allergic rhinitis Allergic rhinitis in which Sx wax and wane as a function of environmental pollen. See Allergic rhinitis. (commonly known as hay fever). Andrx Chief Executive Officer, Richard J. Lane, commented: "We are pleased to announce this tentative approval, which once again reflects the hard work and efforts of our research and development team. We hope this will be the first of several announcements related to the continued movement of our pipeline products through the FDA approval process, the court system and eventually into the marketplace." A tentative approval indicates that FDA has made an initial determination that the application for a generic drug satisfies the substantive requirements for approval, subject to the expiration of all statutorily imposed periods during which approval cannot be granted. Final marketing approval is required for the applicant to market the generic drug. In the case of Claritin-D 24, the underlying chemical entity patent expires on December l9, 2002, so the earliest any generic version of the product could receive FDA final marketing approval would be December 20, 2002. Andrx believes it was the first to file an ANDA for this product, and will be entitled to 180 days of marketing exclusivity upon the grant of its final approval. Andrx has been sued by Schering-Plough for patent infringement of U.S. patents 4,659,716 and 5,314,697. That lawsuit is ongoing. About Andrx Andrx Corporation is a specialty pharmaceutical company engaged in the commercialization of oral controlled-release generic and brand pharmaceuticals utilizing its proprietary drug delivery technologies. Andrx also distributes generic pharmaceutical products manufactured by third parties. Forward-looking statements (statements which are not historical facts) in this release are made pursuant to the safe harbor provisions of 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. For this purpose, any statements contained in this report that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, there can be no assurance as to when or whether the Andrx ANDA for Claritin-D 24 will receive final marketing approval from the FDA, and words such as "may," "will," "to," "expect," "plan," "believe," "anticipate," "intend," "could," "would," "estimate," or "continue" or the negative or other variations thereof or comparable terminology is intended to identify forward-looking statements. Investors are cautioned that all forward-looking statements involve risks and uncertainties, including those risks and uncertainties detailed in the Company's filings with the Securities and Exchange Commission. This release and additional information about Andrx Corporation are also available on the Internet at: http://www.andrx.com |
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