Namenda Immediate-Release Tablets to Stay on Market

May 22, 2015 – An appeals court upheld an injunction requiring Actavis to continue distribution of Namenda (memantine) immediate-release (twice-daily) tablets until August 10, 2015. Namenda as well as Namenda XR extended-release (once-daily) capsules are both used to treat moderate to severe dementia of the Alzheimer’s type. Forest, which is now a subsidiary of Actavis, had planned to discontinue Namenda tablets which would have required patients to switch from Namenda tablets to Namenda XR capsules.  In December 2014, a judge issued a preliminary injunction requiring that Namenda tablets remain on the market until 30 days after generics are available.  Several versions of generic Namenda are expected to be available on July 11, 2015.  The ruling by the appeals court upheld that injunction.

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.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular 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 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.

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