Breckenridge Pharmaceutical, Inc. announces the final approval by the U.S. Food and Drug Administration of the Abbreviated New Drug Application for Gabapentin Oral Solution 250 mg per 5 mL, which is AA rated to Neurontin®, a drug marketed by Pfizer. The product developer, Tris Pharma, will manufacture and supply, and Breckenridge will market and distribute the product.
The Gabapentin Oral Solution annual generic sales totaled $9.3 million based on IMS Health sales data. Gabapentin is indicated as an adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.
The product launch plans are being finalized and the first shipment will occur shortly.
Breckenridge Pharmaceutical, Inc.