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Executive Summary

IVES' CYCLOSPASMOL (CYCLANDELATE) DESI HEARING WILL BE HELD, FDA announced in an Oct. 19 Federal Register notice. A prehearing conference on Cyclospasmol caps and tabs containing cyclandelate is scheduled for Jan. 15, 1985, with notices of participation to be filed no later than Nov. 19. The hearing is in response to requests from the American Home Products subsidiary, as well as Cord Labs, Premo Pharmaceuticals and the Natl. Assn. of Pharmaceutical Mfrs. According to the notice, Ives "primarily relies upon two studies to support an indication for peripheral vascular disease, primarily in patients with arteriosclerosis obliterans . . . and three studies to support an indication for cerebral vascular disease." Noting that Ives "primarily relies upon only four" of 16 efficacy studies submitted for Cyclospasmol, FDA denied the firm's request for a hearing on the agency's 1981 revocation of exemption for the drug. McNeil's Parafon Forte will be the subject of another upcoming DESI hearing, FDA announced in a separate Federal Register notice Oct. 15. The prehearing conference for the chlorzoxazone/acetaminophen combination is set for April 2, 1985, with notices of participation to be filed no later than Nov. 14. In addition to McNeil, Purepac, Ferndale Labs, Danbury and Lemmon have requested a hearing on the agency's proposal to withdraw approval for the drug. In a third DESI notice published the week of Oct. 19, FDA announced the revocation of exemption and opportunity for a hearing on "certain single-entity coronary vasodilators containing pentaerythritol tetranitrate (PETN)." At least eight firms currently market the antianginals: Parke-Davis, Armour, Marion, Zenith, Bolar, Danbury, Phoenix's Vitarine division, Inwood Labs, and Vangard Labs.

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