Posted from: Tuesday, August 04, 2015 - 10:23 AM - Present

Rexulti Approved for Schizophrenia

July 10, 2015 – The U.S. Food and Drug Administration (FDA) approved Rexulti (brexpiprazole) tablets. Manufactured by H. Lundbeck A/S and Otsuka Pharmaceuticals Co., Rexulti is a serotonin-dopamine activity modulator indicated to treat adults with schizophrenia and as an adjunctive therapy for adults with Major Depressive Disorder (MDD). It is thought that the effect of Rexulti on persons with schizophrenia is a result of a combination of partial agonist activity at serotonin 5-HT1A and dopamine D2 receptors, and antagonist activity at serotonin 5-HT2A receptors. Rexulti will be available as 0.25mg, 0.5mg, 1mg, 2 mg, 3mg, and 4 mg tablets and is expected to be launched in early August 2015.  About 2.4 million Americans are affected by schizophrenia while approximately 15 million Americans are affected by MDD. 


Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.

Actual drug patent expiration dates and a availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval.  Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval.  Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability. All trademarks are the property of their respective owners.

*This is provided for information only.  The reference to any medication above does not mean the medication is covered by your plan.

Last Updated Tuesday, November 12, 2019 - 01:41 PM.