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Roxane's Oramorph SR morphine sulfate

Executive Summary

Boehringer Ingelheim subsidiary and Adria Labs begin comarketing 12-hour slow-release morphine for cancer pain in the U.S. The Schedule II Roxane product was approved in 30 mg, 60 mg, and 100 mg doses on Aug. 15. Roxane has marketed the 30 mg dosage since 1984 as a DESI drug under the name Roxanol SR. In 1985, FDA's pilot drug staff required both Roxane and Purdue Frederick to submit NDAs for their products due to their novel sustained release delivery systems. According to Roxane, Adria will provide about 120 of the more than 150 sales reps detailing the product.. ..
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