BRISTOL-MYERS SQUIBB FILES ZERIT (STAVUDINE) NDA
BRISTOL-MYERS SQUIBB FILES ZERIT (STAVUDINE) NDA Dec. 28 for the "treatment of adult patients with HIV infection who have received zidovudine" and for the "treatment of pediatric patients three months to 12 years with symptomatic HIV infection or significant HIV-related immunosuppression." Announcing the filing Jan. 5, BMS noted that the NDA for the nucleoside analog stavudine, or didehydrothymidine (d4T), includes long-term safety and efficacy data from "over 4,400 patients," and "nearly 14,000 patients worldwide" had received d4T as of the NDA submission date.
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