Is Metanx an FDA Approved Drug?

The U.S. Food and Drug Administration (FDA) considers Metanx® a "medical food," as it is a nutritional supplement for a medical condition that has specific nutritional needs. Metanx is used to help manage symptoms of peripheral neuropathy in people with diabetes. It may also be used in people who have high levels of homocysteine in the blood (hyperhomocysteinemia).
 
Although this vitamin requires a prescription, Metanx is not an FDA-approved drug. Therefore, no testing is done to determine if products are equivalent. This means that, technically, there are no generic versions of medical foods, including Metanx.
 
(Click Generic Metanx for more information on why Metanx is not an FDA-approved drug and why there are no generic versions of this product available. This article also describes other products that are similar to Metanx.)
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