FDA Approves First Lyrica Generics

Caroline Cassels


July 22, 2019

The US Food and Drug Administration (FDA) has approved multiple applications for the first generics of pregabalin (Lyrica) for the management of neuropathic pain.

The FDA granted approvals for the generic versions of Lyrica to Alembic Pharmaceuticals, Alkem Laboratories, Amneal Pharmaceuticals, Dr Reddy's Laboratories, InvaGen Pharmaceuticals, MSN Laboratories, Rising Pharmaceuticals, Sciegen Pharmaceuticals, and Teva Pharmaceuticals.

Pregabalin is indicated for neuropathic pain related to diabetic neuropathy, postherpetic neuralgia, and spinal cord injury. It is also used as an adjunctive treatment for partial onset seizures in patients 1 month of age and older and for the management of fibromyalgia.

"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," said 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," Woodcock added.  

Pregabalin must be dispensed with a patient medication guide that contains information about its uses and risks, including the risk of angioedema that may be associated with life-threatening respiratory compromise requiring emergency treatment.

Hypersensitivity reactions such as hives, dyspnea, and wheezing can also occur. In addition, increased seizure frequency or other adverse reactions may occur if the drug is rapidly discontinued.

The FDA also warns that antiepileptic drugs, including pregabalin, increase the risk of suicidal thoughts or behavior. Additionally, pregabalin may cause peripheral edema, so caution should be exercised when co-administering with thiazolidinedione antidiabetic agents. Pregabalin may cause dizziness and drowsiness and impair ability to drive or operate machinery.

The most common side effects reported in clinical trials for Lyrica in adults are dizziness, somnolence, dry mouth, swelling, blurred vision, weight gain, and difficulty with concentration/attention.

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