Faulding Receives Tentative FDA Approval for Labetalol Hydrochloride Injection.NEW YORK--(BUSINESS WIRE)--Dec. 31, 1998--Faulding Hospital Pharmaceuticals, a business unit of international pharmaceutical and healthcare company F H Faulding & Co Limited (Faulding), today announced that its US-based operations had 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. ) of 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 labetalol hydrochloride la·bet·a·lol hydrochloride n. An alpha- and beta-blocker that is used in the treatment of hypertension. labetalol hydrochloride Warning - High-alert drug! Trandate injection, its proposed generic version of Normodyne(R). The product is indicated for control of blood pressure in severe hypertension. There are two brand products for labetalol HCl injection, Normodyne(R) marketed by Schering and Trandate(R) which is marketed by Allen & Handbury. Total brand sales in 1997 were approximately USD USD In currencies, this is the abbreviation for the U.S. Dollar. Notes: The currency market, also known as the Foreign Exchange market, is the largest financial market in the world, with a daily average volume of over US $1 trillion. 16.2 million. The approval is characterised as tentative due to an outstanding patent on the injectable in·ject·a·ble adj. Capable of being injected. Used of a drug. n. A drug or medicine that can be injected. formulation, which is set to expire on 28 November 1999. "This approval is a milestone for us since it is the first ANDA developed by our Aguadilla, Puerto Rico facility. The development effort to achieve this goal has proven to be successful. The approval reflects the dedication and hard work by our development unit in Aguadilla," said Mr Tim Meakin, Chief Executive Officer of Faulding Hospital Pharmaceuticals. The labetalol HCl injection (tentative) approval is the second FDA approval received by Faulding Hospital Pharmaceuticals this calendar year. It previously received approval for butorphanol tartrate butorphanol tartrate a synthetic opioid with both agonist and antiagonist activities. It is used as an analgesic and antitussive. butorphanol tartrate Stadol, Stadol NS Pharmacologic class: Opioid agonist-antagonist , the generic version of Stadol(R) brand injection marketed by Apothecon, on 28 September 1998. Total brand sales in 1997 were approximately USD 22.3 million. Faulding Hospital Pharmaceuticals has filed three additional products with the FDA since the beginning of the 1998/99 financial year and currently has six products awaiting approval with the FDA. These products are in addition to those oral products awaiting approval from the FDA by Faulding Oral Pharmaceuticals. Faulding is a diversified 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 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: Normodyne(R) is a registered trademark of Schering Corporation Trandate(R) is a registered trademark of Glaxo Wellcome Stadol(R) is a registered trademark of Apothecon |
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