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FDA Approves Nine Generic Neuropathy Drugs

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FDA Approves Nine Generic Neuropathy Drugs
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The U.S. Food and Drug Administration (FDA) has approved the first generic versions of Lyrica (generic name pregabalin), a popular medicine used for nerve pain from neuropathy (nerve damage), as well as seizures, fibromyalgia, and other neurological conditions.

Neuropathy is one of the most common diabetic complications, estimated to affect up to 70% of people with diabetes. It typically affects the feet and legs, and sometimes the hands and arms, with symptoms that can include pain, tingling, burning and numbness. Pain from the condition can be difficult to address, with limited treatment options available.

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Approved in 2004, Lyrica is believed to work on damaged nerves, possibly by reducing “extra” electrical signals, but it is not known exactly how the medicine works in the body. According to the Associated Press, the drug costs roughly $460 to $720 per month without insurance, depending on the pharmacy, while prices for the nine newly approved generic versions cost from about $140 to $370 per month.

The most common side effects of the medicine reported in clinical trials are dizziness, sleepiness, dry mouth, swelling, blurred vision, weight gain and abnormal thinking (generally difficulty with concentration/attention).

“Today’s approval of the first generics for pregabalin, a widely-used medication, is another example of the FDA’s longstanding commitment to advance patient access to lower cost, high-quality generic medicines,” stated Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research. “The FDA requires that generic drugs meet rigorous scientific and quality standards. Efficiently bringing safe and effective generics to market so patients have more options to treat their conditions is a top priority for the FDA.”

Want to learn more about diabetic neuropathy? Read “Diabetic Neuropathy,” “Coping With Painful Neuropathy,” “Controlling Neuropathic Pain,” and “Nutrition for Neuropathy.”

 

Diane Fennell

Diane Fennell

Senior Digital Editor for DiabetesSelfManagement.com, Fennell has 16 years’ experience specializing in diabetes and related health conditions. Based in New York City, she has a degree from Columbia University.

 

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