FDA Approves First Generic Lyrica® (Pregabalin)

Since it was first approved in 2004, pregabalin only has been available under the brand name Lyrica®. In July 2019, the Federal Drug Administration (FDA) approved the first generic versions of pregabalin from nine different drug manufacturers. Generic medications typically are more affordable than brand names, meaning more people can have access to the medication if their doctor thinks it is appropriate.

Pregabalin is a medication widely used to treat multiple types of nerve pain*, fibromyalgia, and certain types of seizures.

The drug resembles a substance our bodies naturally produce called GABA and helps balance the chemicals in your brain that sense pain and/or cause seizures. Side effects that may occur while taking this medication may include dizziness, somnolence, dry mouth, swelling, blurred vision, weight gain, and abnormal thinking or difficulty concentrating. Pregabalin is a schedule V medication, meaning it has potential to be addictive or cause people to rely on the medication (dependency). If you think pregabalin may help you, talk to your doctor to see if it is right for you. It is important to understand the risks of any medication prior to taking it. A patient medication guide with information about its uses and risks should be provided for you when you pick up a prescription for pregabalin. Make sure you have read and understood the medication guide before starting, or while taking, pregabalin.

new generic Pregabalin approved

Pregabalin

The FDA is an agency that protects the public by making sure medications, vaccines, and medical devices are proven to be safe and effective.

When considering the approval of generic medications, the FDA makes sure the drug meets very specific and precise standards for quality and safety. Generic medications must demonstrate they contain the same amount of the active drug before they may become available in pharmacies. With the strict approval process set forth by the FDA, you can be sure generic medications are equivalent to the brand name.

*Neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, and neuropathic pain associated with spinal cord injury

Resources:

  1. FDA announcement: https://www.fda.gov/news-events/press-announcements/fda-approves-first-generics-lyrica (https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021446s023s024,022488s001s002s003MedG.pdf)
  2. Lyrica® (pregabalin) medication guide: https://www.fda.gov/files/drugs/published/Lyrica-Medication-Guide.pdf

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