February 04, 2016
A shortage of memantine hydrochloride (Namenda) XR capsules that began in August 2014 has been resolved, according to a report from the U.S. Food and Drug Administration (FDA).
No reason was listed as the cause of the shortage.
Forest Laboratories announced that the following presentations are now available:
- Namenda XR 14 mg Bottle of 30 (NDC 0456-3414-33);
- Namenda XR 14 mg Bottle of 90 (NDC 0456-3414-90);
- Namenda XR 14 mg 10 x 10 Unit Dose: (NDC 0456-3414-63);
- Namenda XR 21 mg Bottle of 30 (NDC 0456-3421-33);
- Namenda XR 28 mg Bottle of 30 (NDC 0456-3428-33);
- Namenda XR 28 mg 10 x 10 Unit Dose (NDC 0456-3428-63);
- Namenda XR Titration Pack: Contains 28 capsules (7 x 7 mg, 7 x 14 mg, 7 x 21 mg, 7 x 28 mg) (NDC 0456-3400-29);
- Namenda XR 28 mg Bottle of 90 (NDC 0456-3428-90).
Memantine hydrochloride XR is approved to treat moderate to severe dementia related to Alzheimer’s disease. The extended release formulation allows for patients to take the medication once daily, versus the twice-daily dosing regimen of its predecessor memantine hydrochloride.
In July 2015, Dr. Reddy’s and Mylan announced the launch of generic versions of memantine hydrochloride.
Memantine hydrochloride made headlines in 2014 when the New York attorney general filed a suit against the drug manufacturer and its parent company Actavis to try to prevent the company from discontinuing the drug shortly before it went off patent in an attempt to force patients to switch to memantine hydrochloride XR.
1. U.S. Food and Drug Administration. FDA drug shortages. www.fda.gov. Accessed February 4, 2016.