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Executive Summary

UNIMED's MARINOL NDA WILL BE RESUBMITTED after the company meets with FDA to discuss the agency's withdrawal of an "approvable letter" for the drug, the company announced in a Nov. 7 press release. Unimed President and CEO Paul Bollenbacher said that the company plans "to move quickly to resubmit the application and satisfy all of their [FDA's] requirements." The company said FDA withdrew the July 31 "approvable letter" for Marinol (dronabinol-THC) because "of certain deficiencies related to two clinical tests which were viewed as pivotol to the agency's ability to judge Marinol as safe and effective." Bollenbacher commented that he was "absolutely dumbfounded by the FDA's decision, since the company has submitted additional data, including labeling information, to the FDA in August." Unimed filed an NDA for Marinol in June 1981. The drug, used to control vomiting and nausea associated with chemotherapy, has been distributed by the Natl. Cancer Institute (NCI) for the last four years. Approximately 800 hospitals, 2,600 doctors, and 25,000 cancer patients have participated in NCI's free THC distribution program, Unimed stated. Unimed has at least two other drugs in clinicals, an anticancer agent Spiro-32 spiro-germanium), and Serc (betahistamine HCI) for the treatment of cerebrovascular disease. The company said it has not been pursuing studies of its L-alpha-acetyl-methadol, a long-acting drug for use in controlled withdrawal from morphine-type addiction, "because of some problems with safety raised by FDA."

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