The FDA has approved several generic versions of pregabalin for the treatment of patients with neuropathic pain related to diabetic neuropathy, postherpetic neuralgia, partial onset seizures, fibromyalgia and 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,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a press release. “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.”
After Pfizer’s patent for pregabalin (Lyrica) expired on December 30, 2018, the company was successful in acquiring a 6-month patent-term extension for pediatric exclusivity, which further postponed the launch of the generic versions. On July 19, 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.
The FDA noted that pregabalin must be dispensed along with a patient medication guide detailing its uses and risks, most notably, the risk for angioedema that may be linked to life-threatening respiratory compromise requiring emergency treatment.
According to the FDA, pregabalin carries an increased risk for hypersensitivity reactions such as hives, dyspnea and wheezing, as well as the possibility of increased seizure frequency and other adverse reactions if the drug is rapidly discontinued.
The FDA also cautioned that pregabalin may cause peripheral edema, and warned against co-administering the drug with thiazolidinedione antidiabetic agents. Additionally, pregabalin has been cited to cause dizziness and drowsiness and may impair the ability to drive or operate machinery.
According to the FDA, the most common adverse events observed for pregabalin included dizziness, somnolence, dry mouth, swelling, blurred vision, weight gain and difficulty with concentration/attention.