8:30 AM
Jun 26, 2018
 |  BC Extra  |  Company News

FDA approves plazomicin for cUTI, but not blood infections

Achaogen Inc. (NASDAQ:AKAO) said FDA approved Zemdri plazomicin to treat complicated urinary tract infections (cUTIs), but issued a complete response letter for the same candidate to treat bloodstream infections. The mixed decision is in line with the outcome of a May FDA advisory committee meeting.

Achaogen shares sank $2.43 (20%) to $9.59 on the news Tuesday.

Zemdri is indicated to treat cUTI, including pyelonephritis, caused by certain Enterobacteriaceae in adults with limited or no alternative treatment options. The U.S. label includes a black box warning for risks of nephrotoxicity, ototoxicity,...

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