Upsher-Smith Receives FDA Approval For Generic Version Of Namenda® (Memantine HCl) Tablets

Memantine Hydrochloride Tablets Indicated for Treatment of Moderate to Severe Dementia of the Alzheimer's Type

Aug 10, 2015, 09:00 ET from Upsher-Smith Laboratories, Inc.

MAPLE GROVE, Minn., Aug. 10, 2015 /PRNewswire/ -- Upsher-Smith Laboratories, Inc. (Upsher-Smith) announced that it has received U.S. Food and Drug Administration (FDA) approval of an abbreviated new drug application (ANDA) for Memantine Hydrochloride Tablets in 5 mg and 10 mg strengths. Memantine Hydrochloride Tablets are equivalent to the branded product, Namenda®, which is indicated for the treatment of moderate to severe dementia of the Alzheimer's type.

"Approximately 5.3 million Americans suffer from Alzheimer's disease," said Rusty Field, President of Upsher-Smith. "With the FDA approval of Upsher-Smith's generic Memantine Hydrochloride Tablets, it is our hope to increase access to a cost-effective alternative to Namenda® for those patients experiencing moderate to severe dementia of the Alzheimer's type." 

Product Information

The NDC number for Memantine Hydrochloride Tablets 5 mg is 0832-1112-60. The NDC number for Memantine Hydrochloride Tablets 10mg is 0832-1113-60.  For questions about ordering Memantine Hydrochloride Tablets, please call Upsher-Smith at 1-800-654-2299.

INDICATIONS

Memantine Hydrochloride Tablets are a prescription medicine used for the treatment of moderate to severe dementia in people with Alzheimer's disease. Memantine Hydrochloride Tablets belongs to a class of medicines called NMDA (N-methyl-D-aspartate) inhibitors.

It is not known if Memantine Hydrochloride Tablets are safe and effective in children.

IMPORTANT SAFETY INFORMATION

Who should NOT take Memantine Hydrochloride Tablets?

Do not take Memantine Hydrochloride Tablets if you are allergic to memantine, the active substance in Memantine Hydrochloride Tablets, or if you have had a bad reaction to Memantine Hydrochloride Tablets or any of its ingredients.

What should I tell my doctor BEFORE taking Memantine Hydrochloride Tablets?

Before taking Memantine Hydrochloride Tablets, tell your doctor about all of your medical conditions, including if you:

  • have or have had seizures
  • have or have had problems passing urine
  • have or have had bladder or kidney problems
  • have liver problems
  • have any other medical conditions
  • are pregnant or plan to become pregnant. It is not known if Memantine Hydrochloride Tablets will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if memantine passes into your breast milk. You and your doctor should decide if you will take Memantine Hydrochloride Tablets or breastfeed.

Also tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Certain medications, changes in diet, or medical conditions may affect the amount of Memantine Hydrochloride Tablets in the body and possibly increase side effects.

What should I watch for AFTER starting Memantine Hydrochloride Tablets?

Memantine Hydrochloride Tablets may cause side effects, including:

  • dizziness
  • headache
  • confusion
  • constipation

These are not all the possible side effects of Memantine Hydrochloride Tablets. For more information, ask your doctor or pharmacist.

How should I take Memantine Hydrochloride Tablets?

Take Memantine Hydrochloride Tablets exactly as your doctor tells you to. Memantine Hydrochloride Tablets may be taken with or without food.

This is the most important information to know about Memantine Hydrochloride Tablets. For more information, talk to your doctor and read the Patient Information leaflet for Memantine Hydrochloride Tablets. You can also visit www.upsher-smith.com or call 1-888-650-3789.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see full Prescribing Information for a complete list of warnings and precautions.

About Upsher-Smith

Upsher-Smith Laboratories, Inc., founded in 1919, is a growing, fully integrated pharmaceutical company dedicated to its mission of delivering high-value, high-quality therapies and solutions which measurably improve individuals' lives. As a family-owned pharmaceutical company, we are able to adapt and thrive in a dynamic healthcare environment. Our world is constantly evolving, and we are continually adapting to the ever-changing needs of patients, physicians, pharmacists, and healthcare organizations. Where there is a need, we will work to deliver solutions that simplify access to treatment, deliver better health outcomes, and enhance life. Upsher-Smith has a particular focus on developing therapies for people living with central nervous system (CNS) conditions, such as seizure disorders. For more information, visit www.upsher-smith.com.

Logo - http://photos.prnewswire.com/prnh/20130520/NY17281LOGO

SOURCE Upsher-Smith Laboratories, Inc.