The FDA on Monday gave Bristol-Myers Squibb Co. approval tomarket the drug, stavudine, for AIDS patients who cannot take AZT orDDI, the two drugs chiefly used in treating the disease .Bristol-Myers, of New York, will sell the drug under the name ZERIT.It's an anti-retroviral agent used to treat adults with advanced HIVinfection. The drug, also known as d4t, inhibits progress of the humanimmunodeficiency virus. A new drug application was initially filed inDecember 1993. A Phase III, multi-center, randomized, double-blindtrial of ZERIT vs. AZT is ongoing.Bristol-Meyers said ZERIT is the first new anti-HIV drug to reach theU.S. market in nearly two years. Initial shipments of the drug towholesalers will begin July 8 and it will be available by prescription.The wholesale price for a bottle of 60 ZERIT 40 milligram capsuleswill be $186.72. The drug will be manufactured in milligram units of40, 30, 20 and 15. The recommended dosage is 40 milligrams, twice aday, according to the company.ZERIT was reviewed under the FDA's accelerated approvalregulations.
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