Lexapro adds long-term data
This article was originally published in Pharmaceutical Approvals Monthly
Lexapro labeling replaces long-term efficacy data on racemic parent, citalopram (Celexa), with 36-week data on escitalopram via an Aug. 29 supplemental approval. Lexapro treatment resulted in a significantly longer time to depression relapse vs. placebo in the 274-patient tria
You may also be interested in...
Deal Snapshot: Six companies seek to collect convalescent plasma from COVID-19 survivors to quickly develop hyperimmune immunoglobulin therapy for serious complications of the virus.
Pharmaceutical companies struggling to keep up with coronavirus-related supply chain havoc asked to keep the US regulator informed as situation unfolds.
Pfizer's third US FDA warning letter since 2018 goes to injectables site in Vizag, India; tells the company to up its game in sterility testing and in the microbiology lab.