The Food and Drug Administration (FDA) has informed that certain Abilify (aripiprazole; Otsuka) formulations will be discontinued before the end of 2015. Discontinuation of the products are not related to any safety or efficacy issues.
The affected products include:
- Abilify Oral Solution 1mg/mL: estimated availability until 5/15/2015
- Abilify Injection for Intramuscular use only 9.75mg/1.3mL: estimated availability until 6/15/2015
- Abilify DISCMELT Orally Disintegrating Tablets 10mg: estimated availability until 7/15/2015
- Abilify DISCMELT Orally Disintegrating Tablets 15mg: estimated availability until 11/30/2015
Abilify contains aripiprazole, an atypical antipsychotic, approved as monotherapy and adjunct therapy for various psychiatric disorders. Conditions include: schizophrenia, manic or mixed episodes in bipolar disorder, major depressive disorder, and irritability associated autistic disorder. The efficacy of aripiprazole is mediated through a combination of partial agonist activity at D2 and 5-HT1A receptors and antagonist activity at 5-HT2A receptors.
Abilify tablets will continue to be available in 2mg, 5mg, 10mg, 15mg, 20mg, and 30mg strengths.
For more information call (800) 438-6055 or visit Otsuka-US.com.