Number of Codeine Tablet Makers To Shrink to One

Cheryl A. Thompson

BETHESDA, MD 13 October 2009— FDA today told four companies to make plans to stop manufacturing and distributing codeine sulfate tablets. The announcement came three months after the agency approved the first new drug application for codeine sulfate tablets.

Roxane Laboratories Inc.'s application was approved on July 16.

FDA said it does not anticipate a supply problem when Roxane becomes the sole manufacturer of codeine sulfate tablets for the U.S. market.

The company's product, available in strengths of 15, 30, and 60 mg, is indicated for the relief of mild to moderately severe pain in patients for whom the use of an opioid analgesic is appropriate.

Cerovene Inc., Dava International Inc., Glenmark Generics Inc., and Lehigh Valley Technologies Inc., were told to stop manufacturing codeine sulfate tablets within 90 days and stop shipping the tablets within 180 days.