Faulding Hospital Pharmaceuticals Receives Tentative FDA Approval for Midazolam Injection.Business Editors/Health Writers ADELAIDE, South Australia--(BUSINESS WIRE)--May 17, 2000 International pharmaceutical and health care company, F H Faulding & Co Limited (Faulding), today announced that its US subsidiary, Faulding Pharmaceutical Co, part of the Faulding Hospital Pharmaceuticals division, has received tentative 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. ) for its 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 ) for midazolam injection, its proposed generic version of Versed (R). Versed(R) is indicated for pre-operative sedation Sedation Definition Sedation is the act of calming by administration of a sedative. A sedative is a medication that commonly induces the nervous system to calm. Purpose The process of sedation has two primary intentions. , anxiolysis and amnesia and is marketed by Roche Laboratories Inc. Total brand sales in 1999 for Versed(R) were approximately US$400 million. The approval is characterised as tentative due to an outstanding patent and additional six month patent protection for paediatric Adj. 1. paediatric - of or relating to the medical care of children; "pediatric dentist" pediatric exclusivity. These will have expired by 20 June 2000 and Faulding will commence marketing the product immediately thereafter. "The midazolam injection approval is an important milestone in the development and forward progress of our US injectable in·ject·a·ble adj. Capable of being injected. Used of a drug. n. A drug or medicine that can be injected. business, as it is one of the most widely used injectable products in the hospital setting", commented Mr Peter Cook, Chief Executive Officer of Faulding Hospital Pharmaceuticals. Mr Cook added, "The approval of midazolam injection further reinforces the commitment from Faulding to building a strong presence in the USA Hospital Pharmaceutical marketplace and adds to the momentum of new products introduced over the past two years." The tentative midazolam injection approval is the fifth FDA approval received by Faulding Pharmaceutical Co during the 1999/2000 financial year. Faulding Pharmaceutical Co has filed five additional ANDAs with the FDA since the beginning of the 1999/00 financial year and currently has six ANDAs awaiting approval with the FDA. These products are in addition to those oral products awaiting approval from the FDA by Faulding's US Oral Division, Purepac Pharmaceutical Co. 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 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 markets its products to and has representation in over 70 countries. Note: Versed(R)is a registered trade mark of Roche Laboratories Inc. N.B. Faulding Company Announcements are posted to the Faulding website www.faulding.com |
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