Industry Briefs
FDA Updates Aricept, Zyprexa Labels
The Food and Drug Administration (FDA) announced last week that it has approved labeling modifications for medicines associated with the product lines of Aricept (donepezil HCl) and Zyprexa (olanazapine)—which include Aricept tablets, Aricept ODT tablets, Aricept Film-Coated tablets, Zyprexa tablets, Zyprexa Zydis, Zyprexa Intramuscular, and Zyprexa Relprevv.
Based on postmarketing experiences reported by patients, the adverse-reaction terms for Aricept—which is intended to treat confusion associated with Alzheimer’s disease—will now also include rhabdomyolysis (breakdown of muscle that causes blood toxicity), QTc prolongation and torsade de points (dangerous forms of heart arrhythmias), and Stevens Johnson syndrome and toxic epidermal necrolysis (rare skin diseases).
Labels for the atypical antipsychotic Zyprexa will now feature a warning for increased risk of othrostatic hypotension. The warning for Zyprexa was based on data from 41 completed clinical trials in adult patients.
FDA to Review Cognitive Claims Linked to Brintellix
Last week, H. Lundbeck A/S and Takeda Pharmaceutical Company announced that the FDA has accepted a Supplemental New Drug Application (sNDA) for Brintellix (vortioxetine) for review. The sNDA adds data regarding the medication’s ability to reduce cognitive dysfunction in adults with major depressive disorder (MDD). The companies are hoping to have these claims added to the label of the selective serotonin reuptake inhibitor next year.
The FDA will review all submitted data supporting the cognitive benefits for Brintellix and decide if a label change is warranted by March 28, 2016. ■
