Description of Medical Areas

About the FDA Approved Listings

Drugs Approved by the FDA

Drug Name: Etodolac Tablets USP, 400mg

The following information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: Royce Laboratories
Approval Status: Approved April 1997
Treatment for: rheumatoid arthritis

General Information

Etodolac Tablets USP, 400mg, have been approved for the treatment of rheumatoid arthritis. Etodolac is the generic equivalent of Wyeth Ayerst’s Lodine Tablets. Etodolac was earlier approved for treating osteoarthritis and managing pain.

Clinical Results

The safety and efficacy for treating rheumatoid arthritis was established in a 3 year double-blind, mulitcenter trial of 1446 patients. In the study 1000mg/day was effective and well tolerated. The recommended starting dose is 600-1000mg/day, divided into two or three doses.


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Drug listing last updated on June 20, 2008

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