Andrx Granted FDA Tentative Approval of Generic Claritin Reditabs.Business Editors/Health & Medical Writers FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--Nov. 18, 2002 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) for loratadine rapidly-disintegrating tablets, which is bioequivalent to Schering-Plough Corporation's Claritin Reditabs(R). Loratadine is an antihistamine antihistamine (ăn'tĭhĭs`təmēn), any one of a group of compounds having various chemical structures and characterized by the ability to antagonize the effects of histamine. and is indicated for the relief 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). This form of loratadine disintegrates in the mouth within seconds of being placed on the tongue, allowing the product to be swallowed with or without water. Brand sales of the product were $331 million in 2001. Andrx Chief Executive Officer, Richard J. Lane, said: "This is our fourth tentative approval in 2002, and we are happy to be on track, moving another of our late stage development products closer to market. As always, I would like to recognize our research and development team for its hard work in this latest Andrx success." The Andrx ANDA for a bioequivalent version of Claritin Reditabs remains the subject of 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. initiated by Schering-Plough. Though the U.S. District Court of New Jersey determined that Schering-Plough's patent (U.S. Patent 4,659,716) is invalid, Schering-Plough has appealed that decision. About Andrx Andrx Corporation is a specialty pharmaceutical company engaged in the formulation and commercialization of oral controlled-release generic and brand pharmaceuticals utilizing its proprietary drug delivery technologies. Andrx also markets and distributes pharmaceutical products manufactured by third parties. This release and additional information about Andrx Corporation are also available on the Internet at: http://www.andrx.com. 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, no assurance can be given as to when or whether the Andrx ANDA for Claritin Reditabs will receive final marketing approval or be launched or the outcome of patent litigation, 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. |
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