Faulding Receives USA FDA Final Approval for Famotidine Injection.Business/Health & Pharmaceutical Editors ADELAIDE, South Australia--(BW HEALTHWIRE)--April 17, 2001 International pharmaceutical and healthcare company, F H Faulding & Co Limited (Faulding), today announced that its Faulding Pharmaceuticals division has received final approval from the US 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 2mL, 4mL and 20mL famotidine injection 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. . Faulding Pharmaceuticals' famotidine injection is the generic equivalent of the Pepcid(R) injection, marketed by Merck & Co, Inc. Pepcid(R) is an anti-ulcer treatment. Brand sales were approximately US$45 million for the 2000 calendar year. Faulding will launch the product immediately. Tentative approval was announced in December 2000. Final approval was delayed due to an outstanding patent and paediatric Adj. 1. paediatric - of or relating to the medical care of children; "pediatric dentist" pediatric exclusivity which expired on 15 April 2001. This is the sixth Faulding Pharmaceuticals' product having received final approval in the United States since the beginning of the financial year. Faulding Pharmaceuticals currently has 12 oral and 5 injectable in·ject·a·ble adj. Capable of being injected. Used of a drug. n. A drug or medicine that can be injected. products on file with the FDA. Faulding is a worldwide pharmaceutical and healthcare 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 oral and injectable pharmaceuticals, consumer health products, the provision of distribution and retail management services to pharmacies and logistics management Logistics Management is that part of Supply Chain Management that plans, implements, and controls the efficient, effective, forward, and reverse flow and storage of goods, services, and related information between the point of origin and the point of consumption in order to meet services to hospitals. Faulding products are sold in over 70 countries. Pepcid(R) is a registered trade mark of Merck & Co, Inc. Company announcements are published on the Faulding website under News at: www.faulding.com/news |
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