FDA Approves First Generics of Lyrica

July 24, 2019

Pregabalin is approved for use in partial onset seizures, as well as postherpetic neuralgia, fibromyalgia, and for the management of neuropathic pain associated with spinal cord injury and diabetic peripheral neuropathy.

Janet Woodcock, MD

The FDA has approved multiple applications for the first generics of pregabalin as an adjunctive therapy for treatment of partial onset seizures in patients 17 years of age and older, as well as the management of neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, fibromyalgia, and neuropathic pain associated with spinal cord injury.

Pfizer's patent for Lyrica expired on July 19th, clearing the way for several generic versions of the drug to enter the market. Generic manufacturers plan to make the drug available in doses of 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg capsules.

The agency requires pregabalin to be dispensed with a patient medication guide that contains important information about its uses and risks. The guide covers warnings for serious adverse events, including angioedema, as well as hypersensitivity reactions such as hives, dyspnea, and wheezing. The agency also points out that increased seizure frequency can occur if the drug is discontinued rapidly. Like many antiseizure medications, pregabalin may increase the risk for suicidal thoughts or behavior. The drug is also associated with a risk for peripheral edema of the hands and legs, and should be cautiously used in patients who are also receiving thiazolidine-dione antidiabetic drugs.

The most common side effects reported in the clinical trials in adults receiving pregabalin were dizziness, somnolence, dry mouth, swelling, blurred vision, weight gain, and abnormal thinking.

“[The] 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,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a statement. “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.”

The FDA granted approval for the generic versions of pregabalin to Alembic Pharmaceuticals, Alkem Laboratories, Amneal Pharmaceuticals, Dr. Reddy’s Laboratories, InvanGen Pharmaceuticals, MSN Laboratories Ltd., Rising Pharmaceuticals, Inc., Sciegen Pharmaceuticals Inc., and Teva Pharmaceuticals.

REFERENCE

FDA approves first generics of Lyrica [news release]. Silver Spring, MD: FDA. July 22, 2019. https://www.fda.gov/news-events/press-announcements/fda-approves-first-generics-lyrica. Accessed July 23, 2019.