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Biotech / Medical : Pharma News Only (pfe,mrk,wla, sgp, ahp, bmy, lly) -- Ignore unavailable to you. Want to Upgrade?


To: Henry Niman who wrote (1136)11/24/1998 10:56:00 AM
From: Anthony Wong  Respond to of 1722
 
[AHP IVX] Ivax gets approval for osteoarthritis drug
Tuesday November 24, 9:10 am Eastern Time

MIAMI, Nov 24 (Reuters) - Pharmaceuticals firm IVAX Corp. said Tuesday the U.S. Food and Drug Administration approved its Abbreviated New Drug Application for a generic anti-inflammatory tablet to manage osteoarthritis and pain.

Its etodolac 500 mg nonsteroidal drug is the generic equivalent of Wyeth-Ayerst Laboratories' (NYSE:AHP - news) Lodine and will be marketed by IVAX's wholly-owned subsidiary, Zenith Goldline Pharmaceuticals, Inc., with shipping to begin commence shortly.

The Zenith Goldline unit now has approvals to manufacture and market etodolac in 200 and 300 mg capsules, and 400 and 500 mg tablets.

''This application was approved on a first cycle review which demonstrates the quality of our generic drug applications,'' said Dr. Rafick Henein, Zenith Goldline's president and chief executive officer. ''We have recently filed several additional ANDAs, bringing to 18 the total number of applications now pending in the U.S.''

Its shares closed at 9-3/4 in Monday trading on the American Stock Exchange.