Faulding Receives US FDA Approval For Extended-Release Isosorbide Mononitrate Tablets.UNDERDALE, South Australia--(BUSINESS WIRE)--Jan. 5, 1998-- International pharmaceutical and healthcare company, F H Faulding & Co Limited (Faulding), today announced that its US-based subsidiary, Purepac Pharmaceutical Co, part of Faulding Oral Pharmaceuticals, 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. ) on 31 December 1998 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 extended-release isosorbide mononitrate tablets. Mr. Richard Moldin, Chief Executive Officer of Faulding Oral Pharmaceuticals, said "Our 30 mg and 60 mg extended-release isosorbide mononitrate tablets are the generic equivalent of Imdur(R) brand tablets, marketed by Key Pharmaceuticals. The tablets are indicated for the prevention of angina pectoris due to coronary heart disease coronary heart disease: see coronary artery disease. coronary heart disease or ischemic heart disease Progressive reduction of blood supply to the heart muscle due to narrowing or blocking of a coronary artery (see atherosclerosis). . The product had brand name sales for the 12 months ended September 1998 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. 250 million. Purepac believes that it is the first independent generic pharmaceutical company to receive clearance to market the 30 mg tablets. Generic equivalents for the 60 mg strength have been marketed since November 1998. Purepac will commence commercial shipment of the product immediately." Dr. Ed Tweddell, Group Managing Director/Chief Executive Officer of Faulding, said "This is a significant approval for the Company. The market for the product is substantial and Faulding will be the first independent generic company to market this dosage size." The approval of extended-release isosorbide mononitrate tablets was the seventh FDA approval received by Purepac in 1998. Previously Faulding announced approvals for Naproxen DR Tablets, 500 mg etodolac etodolac /eto·do·lac/ (e-to-do´lak) a nonsteroidal antiinflammatory drug used as an analgesic and antiinflammatory, especially to treat arthritis. e·to·do·lac n. tablets, ticlopidine HCL tablets (tentative), diltiazem HCL extended-release tablets (tentative), immediate-release isosorbide mononitrate 10 mg and 20 mg tablets and phentermine phentermine /phen·ter·mine/ (fen´ter-men) a sympathomimetic amine related to amphetamine, used as an anorectic either as the hydrochloride salt or as the base complexed with an ion exchange resin. hydrochloride tablets. 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: Imdur(R) is a registered trademark of Key Pharmaceuticals, Inc. |
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