Faulding Receives Tentative FDA Approval for Famotidine Injection.Business/Health Editors ADELAIDE, South Australia--(BUSINESS WIRE)--Dec. 15, 2000 International pharmaceutical and healthcare company, F H Faulding & Co Limited (Faulding), today announced that its Faulding Pharmaceuticals division has received tentative 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 Pepcid(R) injection, marketed by Merck. Pepcid(R) is an anti-ulcer treatment. Brand sales were approximately US$62 million for the 1999 calendar year. The approval is tentative at this stage due to an outstanding patent and paediatric Adj. 1. paediatric - of or relating to the medical care of children; "pediatric dentist" pediatric exclusivity which expires on 15 April 2001. Faulding Pharmaceuticals will commence marketing the product immediately thereafter. This is the sixth Faulding Pharmaceuticals' product approved 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 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 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. |
|
||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion