Vi­a­tris with­draws ac­cel­er­at­ed ap­proval for top­i­cal an­timi­cro­bial 24 years lat­er

Af­ter 24 years with­out con­firm­ing clin­i­cal ben­e­fit, the FDA an­nounced Tues­day morn­ing that Vi­a­tris (formed via My­lan and Pfiz­er’s Up­john) has de­cid­ed to with­draw a top­i­cal an­timi­cro­bial agent, Sul­famy­lon (mafenide ac­etate), af­ter the com­pa­ny said con­duct­ing a con­fir­ma­to­ry study was not fea­si­ble.

Sul­famy­lon first won FDA’s ac­cel­er­at­ed nod in 1998 as a top­i­cal burn treat­ment, with the FDA not­ing that last De­cem­ber, My­lan told the agency that it wasn’t run­ning the tri­al.

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