FDA Tentatively Approves Andrx ANDA For Tiazac.Business Editors/Health & Medical Writers FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--Oct. 2, 2000 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 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 ) Andrx filed for Taztia XT(TM), its bioequivalent version of Tiazac(R). Manufactured by Biovail Corporation and marketed by Forest Laboratories, Tiazac(R) is a once-a-day Diltiazem Hydrochloride Extended-release Capsule used in the treatment of hypertension and chronic stable angina chronic stable angina Cardiology The most common form of angina, characterized by chest discomfort due to myocardial ischemia, and unaccompanied by myocardial necrosis; the cause of pain is uncertain, possibly substances released during transient ischemia–eg, , with 1999 U.S. sales of approximately $170 million. The FDA will grant final approval of the Andrx ANDA for Taztia XT(TM), when the Court of Appeals upholds the lower court's decision that the Andrx product does not infringe the patent claims of Biovail and its affiliates or when the 30 month statutory period expires in the 2001 first quarter, whichever is earlier. 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 selected high sales volume controlled-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 drug delivery technologies. Andrx also markets and distributes pharmaceutical products manufactured by third parties. Andrx' Cybear Group (Nasdaq:CYBA) intends to use the Internet to improve the efficiency of administrative and communications tasks of managing patient care - while addressing the healthcare industry's critical need for secure and reliable transmission of information. 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," "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 risks and uncertainties, including those risks and uncertainties detailed in the Company's filings with the Securities and Exchange Commission. Andrx is located at 4001 S.W. 47th Avenue, Fort Lauderdale, Fla. 33314. This release and additional information about Andrx Corporation are also available on the Internet at: http://www.andrx.com |
|
||||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion