Faulding receives final FDA approval for doxazosin tablets.Business Editors/Pharmaceutical & Healthcare Writers ADELAIDE, South Australia--(BUSINESS WIRE)--Oct. 19, 2000 International pharmaceutical and healthcare company, F H Faulding & Co Limited (Faulding), today announced that its US subsidiary, Purepac Pharmaceutical Co., has received approval from the Food and Drug Administration (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. ) to manufacture and market doxazosin mesylate dox·a·zo·sin mesylate n. An alpha-blocker drug used to treat hypertension and benign prostatic hyperplasia. doxazosin mesylate (doksā´zōsin mes´ilāt´), n brand name: tablets. The 1mg, 2mg, 4mg and 8mg doxazosin mesylate tablets are the generic equivalent of Cardura(R) brand tablets marketed by Pfizer Inc. Cardura(R) is indicated for the treatment of hypertension and benign prostate hyperplasia Benign prostate hyperplasia (BPH) Enlargement of the prostate gland. Mentioned in: Paruresis . Annual brand sales were US$290 million for the year ending 30 June 1999. Faulding expects to launch the product immediately. This is the third product launched by Faulding in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. since the beginning of the financial year. Purepac currently has 12 additional Abbreviated New Drug Applications 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 (ANDAs) on file with the FDA. Faulding is a world-wide health and personal care company, listed on the Australian Stock Exchange Australian Stock Exchange (ASX) Australia's major securities market, formed when the six state stock exchanges (Adelaide, Brisbane, Hobart, Melbourne, Perth, and Sydney stock exchanges) were merged in 1987. . Faulding's principal businesses are generic oral and injectable pharmaceuticals, consumer health products, the provision of distribution and retail management services to pharmacies and logistics management services to hospitals. Faulding products are sold in over 70 countries. NOTE: Cardura(R) is a registered trade mark of Pfizer Inc. N.B.: Faulding Company Announcements are posted to the Faulding website www.faulding.com |
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