Sunovion Sales Rep Draws FDA Promotional Letter For Declaring Broader Latuda Label Inevitable
This article was originally published in The Pink Sheet Daily
Executive Summary
While admitting that Sunovion Pharmaceuticals Inc.’s schizophrenia drug Latuda (lurasidone) does not yet have an indication for bipolar I disorder, a sales rep told a psychiatrist it could still be used to treat that condition, FDA’s Office of Prescription Drug Promotion says in a “notice of violation” letter.
You may also be interested in...
New Indications For Sunovion’s Latuda Mean New Marketing Strategy
The Japanese pharma gained two more indications for the atypical antipsychotic and hopes to differentiate it by stressing its approval as both a monotherapy and adjunctive therapy to standards of care.
Could Forest's DDMAC Letter For Off-Label Promotion Doom CEO Solomon?
A physician complained to FDA's "Bad Ad" program about a Forest Laboratories sales representative's off-label claims for the fibromyalgia drug Savella.
Janssen’s Sirturo Needs Minor Tweaks To Confirmatory Trial, FDA Panel Says
Gathering more data to assuage concerns about possibly lower efficacy in black patients will be key to converting the accelerated approval to full approval for the tuberculosis drug, FDA’s Anti-Infective Drugs Advisory Committee concludes.