Business Wire - Andrx Announces FDA Approvable Letter for Cardura XL
FORT LAUDERDALE, Fla. — Andrx Corporation (”Andrx” or “Company”) (Nasdaq:ADRX) today announced that the United States Food and Drug Administration (”FDA”) has issued an approvable letter for Pfizer Inc.’s (”Pfizer”) New Drug Application (”NDA”) for Cardura(R) XL, a sustained-release formulation of doxazosin mesylate, used to treat benign prostatic hyperplasia (BPH). As previously announced, Andrx will receive exclusive distribution rights to Cardura XL in the United States upon the approval of the product with certain minimum claims. The FDA’s approvable letter sets out the conditions that must be met before final marketing approval is obtained. Pfizer has responsibility for the NDA and has informed us that it intends to respond promptly to the conditions of the approvable letter.
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About Andrx Corporation
Andrx Corporation is a pharmaceutical company that: develops and commercializes generic versions of controlled-release brand name pharmaceuticals, using the Company’s proprietary controlled-release drug delivery technologies, and generic versions of niche and immediate-release pharmaceutical products, including oral contraceptives; distributes pharmaceuticals, primarily generics, manufactured by others as well as manufactured by the Company, primarily to independent pharmacies, pharmacy chains, pharmacy buying groups and physicians’ offices; and commercializes brand pharmaceuticals, in some instances using the Company’s proprietary controlled-release drug delivery technologies.
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 of 1995. For this purpose, any statements contained herein or which are otherwise made by or on behalf of the Company 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,” ” plan,” “expect,” “believe,” “anticipate,” “intend,” “could,” “would,” “estimate,” or “continue” or the negative other variations thereof or comparable terminology are intended to identify forward-looking statements. Investors are cautioned that all forward-looking statements involve risk and uncertainties, including but not limited to, the Company’s dependence on a relatively small number of products; licensing revenues; the timing and outcome of patent, antitrust and other litigation; the timing and commercial success of future generic product launches; whether the Company will be awarded any market exclusivity period and, if so, the precise dates thereof; government regulation generally; competition; manufacturing capacities, output and quality processes; the Company’s ability to develop and successfully commercialize new products; the loss of revenues from existing products; development and marketing expenses that may not result in commercially successful products; the Company’s inability to obtain, or the high cost of obtaining, licenses for third party technologies; commercial obstacles to the successful introduction of brand products generally, including Cardura XL; the success of the Company’s joint ventures; the impact of returns, allowances and chargebacks; product liability claims; and the absence of certainty regarding the receipt of required regulatory approvals or the timing or terms of such approvals. Andrx Corporation is also subject to other risks detailed herein or detailed from time to time in its filings with the U.S. Securities and Exchange Commission. Andrx disclaims any responsibility to update the statements contained herein.
This release and additional information about Andrx Corporation are also available on the Internet at: http://www.andrx.com.
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