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Andrx Receives Approvals for Generic Claritin-D 24 and Nolvadex.


Business Editors/Health/Medical Writers

FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--Feb. 24, 2003

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 approved the marketing of its Abbreviated New Drug Applications ("ANDA ANDA
abbr.
abbreviated new drug application
") for its bioequivalent of Schering-Plough's Claritin-D(R) 24 Hour Extended Release Tablets ("Claritin-D 24"), with a 180-day period of exclusivity, and for its 10 mg and 20 mg generic equivalents of AstraZeneca's Nolvadex(R) tablets.

Claritin-D 24 is Loratadine/Pseudoephedrine Sulfate 10mg/240mg extended-release tablets, a once daily decongestant decongestant /de·con·ges·tant/ (de?kon-jes´tint)
1. tending to reduce congestion or swelling.

2. an agent that so acts.


de·con·ges·tant
n.
 used to relieve 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). Though Claritin-D 24 had 2002 U.S. prescription sales of approximately $480 million, in November 2002, the FDA approved the use of this and the other Claritin line of products, at their original prescription strengths, as over-the-counter (OTC OTC

See: Over-the-counter.


OTC

See over-the-counter market (OTC).
) medicines. In response to this development, Andrx entered into its previously announced agreement with Perrigo Company, the nation's largest provider of store brand over-the-counter pharmaceuticals, for Perrigo to market Andrx's bioequivalent versions of Claritin products (Claritin-D 24, and when approved, Claritin-D(R) 12 and Claritin Reditabs(R)) as OTC products. Andrx anticipates that Perrigo's first shipments of Claritin-D 24 will begin by mid-2003.

Nolvadex is Tamoxifen Citrate, used in the treatment of breast cancer, which had 2002 U.S. brand and generic sales totaling approximately $500 million. With the expiration of pediatric pediatric /pe·di·at·ric/ (pe?de-at´rik) pertaining to the health of children.

pe·di·at·ric
adj.
Of or relating to pediatrics.
 exclusivity, numerous generic competitors have already entered the market at the same time, which has resulted in substantial pricing erosion. Rather than launching its tamoxifen citrate product, Andrx is both preparing itself for other more significant launch opportunities, including the Claritin family of products, and working to remedy the issues relating to its manufacturing capacity constraints and inefficiencies.

About Andrx

Andrx is engaged in the formulation and commercialization of oral controlled-release pharmaceuticals utilizing its proprietary drug delivery technologies. In its ANDA program, Andrx is developing generic versions of controlled-release or specialty, niche or immediate release brand name pharmaceuticals. In its NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any  program, Andrx is developing its own brand name formulations of certain existing drugs that it believes may be improved by the application of Andrx's drug delivery technologies. Andrx also markets and distributes 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, 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 but not limited to Andrx's ability to manufacture, and Perrigo's ability to market, Claritin-D 24 as described herein as well as Andrx's results of operations. The Company is also subject to other risks as detailed from time-to-time in the Company's filings with the Securities and Exchange Commission.
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Publication:Business Wire
Geographic Code:1USA
Date:Feb 24, 2003
Words:519
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