New Strengths and Broadened Indications for Namzaric
July 18, 2016 – The U.S. FDA approved two new strengths for Namzaric®, an extended-release capsule containing memantine and donepezil as well as a new indication. Namzaric, manufactured by Allergan, is indicated to treat dementia associated with Alzheimer’s disease. Originally it received FDA approval in December 2014 for patients taking both donepezil and memantine separately for moderate-to-severe Alzheimer’s-type dementia. Now, Namzaric is approved for patients taking only 10mg of donepezil per day. The new strengths are 7mg memantine/10mg donepezil and 21mg memantine/10mg donepezil and will be released in September, according to Allergan. Namzaric is already available in 14mg memantine/10mg donepezil and 28mg memantine/10mg donepezil capsules. For patients transitioning from donepezil monotherapy it is recommended that the initial dose start at the lowest strength capsule, increasing incrementally by 7mg memantine per week up to a maintenance dose of one highest strength capsule per day.
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.