On July 19, the U.S. Food and Drug Administration approved multiple applications for first generics of Lyrica (pregabalin) for the management of neuropathic pain associated with diabetic peripheral neuropathy, for the management of postherpetic neuralgia, as an adjunctive therapy for the treatment of partial onset seizures in patients 17 years of age and older, for the management of fibromyalgia, and for the management of neuropathic pain associated with spinal cord injury.
“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, M.D., 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.”
Pregabalin must be dispensed with a patient Medication Guide that contains important information about its uses and risks. Warnings include the risk of angioedema (swelling of the throat, head and neck), which may be associated with life-threatening respiratory compromise requiring emergency treatment. Hypersensitivity reactions such as hives, dyspnea (difficulty breathing) and wheezing can occur. Increased seizure frequency or other adverse reactions may occur if the drug is rapidly discontinued. Antiepileptic drugs, including pregabalin, increase the risk of suicidal thoughts or behavior. Additionally, pregabalin may cause peripheral edema (swelling of hands or legs) so caution should be exercised when co-administering it 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 the clinical trials for Lyrica in adults are dizziness, somnolence, dry mouth, swelling, blurred vision, weight gain and abnormal thinking (primarily difficulty with concentration/attention).
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 Ltd., Rising Pharmaceuticals, Inc., Sciegen Pharmaceuticals Inc., and Teva Pharmaceuticals.
Addressing the challenges related to developing generics and promoting more generic competition is a key part of the Drug Competition Action Plan and the agency’s efforts to help advance patient access to more affordable medicines.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.