First Generic Lyrica Capsules Approved by FDA

July 22, 2019

Distributed by Invagen, a subsidiary of Cipla Ltd.

The FDA has approved the first generic capsules of pregabalin (Lyrica, Pfizer). The new capsules will be distributed by Invagen, a subsidiary of Cipla Ltd. 

Like the brand name, Cipla’s AB-therapeutic-equivalent Pregabalin Capsules (25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg) are indicated for the management of: 

 

  • Neuropathic pain associated with diabetic peripheral neuropathy 

  • Postherpetic neuralgia

  • Fibromyalgia

  • Neuropathic pain associated with spinal cord injury

The capsules will also be indicated as an adjunctive treatment of partial-onset seizures in pediatric patients. However, unlike the brand name, Cipla’s generics are only approved for use in patients 17 years of age and older, compared to the approved use in patients as young as 1 month old in Pfizer’s Lyrica. 

"[The] 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 in a statement. "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 is contraindicated for patients with a known hypersensitivity to pregabalin or its components. 

Prescribing information for pregabalin contains warnings of angioedema, hypersensitivity reactions, increased risk of suicidal thoughts or behaviors, potential peripheral edema, potential dizziness and somnolence, as well as impaired ability to drive or operate machinery. Rapid discontinuation of pregabalin may result in increased seizure frequency or other adverse reactions. 

Adverse reactions reported with the use of pregabalin include dizziness, somnolence, dry mouth, edema, blurred vision, weight gain, and abnormal thinking (primarily difficulty with concentration/attention).

 

Full Prescribing Information (Lyrica)