Faulding Receives FDA Approval for Bleomycin Sulfate for Injection.Business & Medical/Health Editors ADELAIDE, South Australia--(BUSINESS WIRE)--March 15, 2000 International pharmaceutical and health care company F H Faulding & Co Limited (Faulding) today announced that its USA-based injectable products division of Faulding Hospital Pharmaceuticals 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. ) 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 bleomycin sulfate bleomycin sulfate Warning - Hazardous drug! Blenoxane Pharmacologic class: Antitumor antibiotic Therapeutic class: Antineoplastic Pregnancy risk category D for injection. "Our bleomycin sulfate for injection is the generic equivalent of Bristol-Myers Squibb's Blenoxane(R) and is indicated for management of certain neoplasms which include lymphomas, squamous cell and testicular testicular /tes·tic·u·lar/ (tes-tik´u-lar) pertaining to a testis. tes·tic·u·lar adj. Of or relating to a testicle or testis. testicular pertaining to the testis. carcinoma. Total sales of bleomycin sulfate for injection in 1999 were approximately US$26 million", said Mr Peter Cook, Chief Executive Officer, Faulding Hospital Pharmaceuticals. "This approval is an important milestone in the continuing development of our USA injectable business, as the product enhances our oncology portfolio and total presence in the American hospital market," added Mr Cook. The bleomycin sulfate for injection approval is the fourth USA FDA approval received by Faulding Hospital Pharmaceuticals this financial year. The three other approvals include the final approval for labetalol HCI (Human Computer Interaction) Refers to the design and implementation of computer systems that people interact with. It includes desktop systems as well as embedded systems in all kinds of devices. and cytarabine 2g/20mL during November 1999 and December 1999 respectively, and the tentative approval for enalaprilat injection in February 2000. Faulding Hospital Pharmaceuticals has filed three additional ANDAs with the FDA since the beginning of the 1999/00 financial year and has a total of five ANDAs awaiting approval with the FDA. These products are in addition to those products awaiting approval from the FDA by Purepac Pharmaceutical Co, a division of Faulding Oral Pharmaceuticals. 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 markets its products to and has representation in over 70 countries. Note: Blenoxane(R)is a registered trade mark of the Bristol-Myers Squibb Company. N.B. Faulding Company Announcements are posted to the Faulding website www.faulding.com |
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