Breaking News

Achaogen Reports Upgraded Status for Plazomicin Fill Manufacturer

McPherson, KS facility compliance status amended to Voluntary Action Indicated (VAI)

Author Image

By: Tim Wright

Editor-in-Chief, Contract Pharma

Achaogen, Inc., a late-stage biopharmaceutical company developing antibacterials for multi-drug resistant (MDR) gram-negative infections, said that the U.S. FDA has classified the outcome of its fourth quarter 2017 re-inspection of Pfizer’s McPherson, KS facility as Voluntary Action Indicated (VAI). The company’s new drug application (NDA) for plazomicin is currently under regulatory review, and the change to VAI status provides a clear regulatory path for approval for plazomicin out of the McPh...

Continue reading this story and get 24/7 access to Contract Pharma for FREE


Already a subscriber? Sign in

Keep Up With Our Content. Subscribe To Contract Pharma Newsletters