Faulding Receives First Generic Approval for Spironolactone Tablets USP, 50 mg and 100 mg.UNDERDALE, South Australia--(BUSINESS WIRE)--July 30, 1999-- International pharmaceutical and health care company, F H Faulding & Co Limited (Faulding), today announced that its US-based subsidiary, Purepac Pharmaceutical Co. received 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. ) on July 29, 1999 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 for spironolactone spironolactone /spir·o·no·lac·tone/ (spi?rah-no-lak´ton) one of the spirolactones, an aldosterone inhibitor that blocks the aldosterone-dependent exchange of sodium and potassium in the distal tubule, thus increasing excretion of sodium tablets USP USP - unique sales point , 50 mg and 100 mg. Mr. Richard Moldin, Chief Executive Officer of Faulding Oral Pharmaceuticals, said "Our 50 mg and 100 mg spironolactone tablets are the generic equivalent of Aldactone(R) brand tablets, marketed by G.D. Searle & Co. Spironolactone is a pharmacological antagonist of the hormone aldosterone, and acts as a diuretic and antihypertensive drug by this mechanism. The product is indicated in the management of primary hyperaldosteronism and edematous conditions (the retention of water) for patients with a number of medical conditions, including congestive heart failure congestive heart failure, inability of the heart to expel sufficient blood to keep pace with the metabolic demands of the body. In the healthy individual the heart can tolerate large increases of workload for a considerable length of time. . "The product had brand name sales for the 12 months ended March 1999 of 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. 38 million. Purepac believes that it is the first generic pharmaceutical company to receive clearance to market the product in 50 mg and 100 mg strengths. Purepac expects to commence commercial shipment of the product shortly." Dr. Ed Tweddell, Group Managing Director/Chief Executive Officer of Faulding, said "This is a significant approval for the Company. While the market for the product is relatively modest, Faulding expects to be the first generic company to market this dosage size, and hopes to capture and retain a significant share of the market." Faulding is a diversified worldwide health and personal care company which is publicly 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 generic and branded pharmaceuticals, injectable generic pharmaceuticals, consumer health products, the provision of distribution and retail management services to retail pharmacies, and logistics management services to hospitals. Faulding markets its products and is represented in more than 70 countries worldwide. Note: Aldactone(R) is a registered trademark of G.D. Searle & Co. |
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