New Indication for Abilify Maintena
July 28, 2017 – The U.S. FDA has approved a new indication for Abilify Maintena®, manufactured by Otsuka, as a single agent for maintenance treatment of adults who have bipolar I disorder. An atypical antipsychotic drug, Abilify Maintena has a recommended dose of 400mg given by intramuscular (IM) injection once a month, and should be administered by a healthcare professional. The drug was originally approved for the treatment of schizophrenia. It carries a black box warning cautioning against its use as treatment for dementia-related psychoses in elderly patients due to a potential increased risk of death.
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 U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and 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.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.