The FDA granted the approvals to Alembic Pharmaceuticals, Alkem Laboratories, Amneal Pharmaceuticals, Dr. Reddy’s Laboratories, InvaGen Pharmaceuticals, MSN Laboratories Ltd., Rising Pharmaceuticals, Sciegen Pharmaceuticals, and Teva Pharmaceuticals.
Pregabalin is the AB generic equivalent to Pfizer‘s Lyrica, an anti-epileptic drug (anticonvulsant) that has been approved by the FDA for the treatment of fibromyalgia and neuropathic (nerve) pain associated with diabetes (diabetic neuropathy), herpes zoster (post-herpetic neuralgia), or spinal cord injury.
The medication works by slowing the propagation of electrical signals in the brain that causes seizures, which is also the reason why pregabalin is sometimes used together with other treatments to control seizures in adults and children. It also works by affecting the operation of certain brain chemicals associated with pain signals.
An AB generic is a medication that has been shown to be equivalent, from a biological and biochemical standpoint, to the brand-name product in preclinical studies. It is the most common designation among generic medications.
“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,” she added.
With the new approval, pregabalin capsules will be immediately available to patients living in the U.S. for the following:
- Management of nerve pain associated with diabetic peripheral neuropathy.
- Management of postherpetic neuralgia.
- Add-on therapy for the treatment of seizures in patients 17 or older.
- Management of chronic pain associated with fibromyalgia.
- Management of nerve pain associated with spinal cord injury.
The companies had submitted abbreviated new drug applications for the compound, which are filed for generic medications seeking FDA approval. Once a medication is approved, the companies earn the right to manufacture and market the therapy as an equally safe, effective, and less-expensive alternative to the brand-name product — in this case, Lyrica.
InvaGen stated in a press release that its capsules will be available in doses of 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg.
According to IQVIA, Lyrica sales reached approximately $5.4 billion in the last year in the U.S.