Andrx Granted FDA Final Marketing Approval for Naprelan
Wednesday August 28, 7:59 am ET
FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--Aug. 28, 2002--Andrx Corporation (Nasdaq:ADRX - News) today announced that the United States Food and Drug Administration (FDA) has approved the marketing of its Abbreviated New Drug Application (ANDA) for a 500-mg strength of naproxen sodium, a non-steroidal anti-inflammatory drug, which is bioequivalent to Naprelan®. Marketed by Elan Corporation, the 500-mg strength of Naprelan had 2001 brand sales of approximately $25 million. Naprelan is used for the treatment of pain caused by arthritis, osteoporosis and other inflammatory conditions. Andrx plans to begin marketing its generic version of Naprelan in September 2002.
Larry Rosenthal, Andrx Pharmaceuticals' Executive Vice President of Sales and Marketing said, "We are proud to announce another first for Andrx and we are hopeful that this represents the start of an exciting second half of the year."
Andrx also has a 375-mg generic version of Naprelan, which has FDA tentative approval. As the 30-month period for the 375-mg strength of Naprelan will not expire until December 2002, absent a final and unappealable court decision in the Company's pending patent dispute with Elan, FDA is unable to grant final approval of the 375-mg strength of the Andrx product until that time.
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: 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 of 1995. For this purpose, any statements contained in this release 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 those risks and uncertainties, including but not limited to, the commercial launch and approval of the products described herein and 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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Contact:
Andrx Corporation, Fort Lauderdale
Investor Relations
Gale A. Blackburn, 954/217-4344
gblackburn@andrx.com
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Source: Andrx Corporation
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