Reflecting On FDA Approval Of New TB Drug

Noting “[t]he U.S. Food and Drug Administration (FDA) recently announced that it has approved a new treatment for multidrug-resistant [tuberculosis (TB)] that can be used as an alternative when other drugs fail,” Kim Lufkin, communications officer at the Global Health Technologies Coalition (GHTC), writes in the coalition’s “Breakthroughs” blog, “There is a pressing and urgent need for even more new TB drugs, which makes this new FDA approval so significant.” She continues, “It is also noteworthy that the FDA approved Sirturo under its accelerated approval program, in addition to granting the drug fast track, priority review, and orphan-product status,” adding, “It’s critical that the FDA continues to support its priority review, fast track, and similar programs, which can help speed access to safe and effective global health drugs” (1/3).

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