New Drug Approvals In 2003 Could Include Four HIV Agents
This article was originally published in Pharmaceutical Approvals Monthly
FDA’s new molecular entity approval totals for 2003 could feature as many as four novel HIV agents.
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FDA has at least 28 pending applications with user fee deadlines in October, including seven NMEs and one new biologic.
FDA closed the first quarter of 2003 with three new molecular entity approvals, all in March.
FDA approved approximately one-third of new molecular entities with user fee deadlines in 2002 on the first cycle.