FDA approves generic version of Lyrica to cut treatment costs
Food and drug administration(FDA) has approved generic version of Lyrica to cut treatment costs.
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.
The Food and drug administration(FDA)
granted approvals for the generic versions of Lyrica to nine companies including Alembic Pharmaceuticals, Alkem Laboratories, Amneal Pharmaceuticals, Dr. Reddy’s Laboratories, InvaGen Pharmaceuticals, MSN Laboratories Ltd., Rising Pharmaceuticals, Inc., Sciegen Pharmaceuticals Inc., and Teva Pharmaceuticals.
“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).
Each year, FDA’s Center for Drug Evaluation and Research (CDER) approves a wide range of new drug products.Food and drug administration (FDA) provides the scientific and regulatory advice needed to bring safe, effective, high-quality generic alternatives to market, which in turn creates more affordable treatment options for patients.
“First generics” are just what they sound like—the first approval by Food and drug administration which permits a manufacturer to market a generic drug product in the United States. FDA considers first generics to be important to public health, and prioritizes review of these submissions.