BOCA RATON, Fla., March 17, 2016 /PRNewswire/ -- 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. is a privately-held own label Distributor that performs pharmaceutical research and development as well as marketing and distribution in the U.S. The company was founded in 1983 and markets a broad range of generic prescription products in many therapeutic categories. The Breckenridge label is recognized by wholesalers, distributors, chains, and managed care accounts, as well as retail pharmacies nationwide. The company markets over 70 products in a variety of dosage forms including: tablets, capsules, soft gel capsules, liquids, suspensions, ophthalmics, nasal sprays and powders. www.bpirx.com
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SOURCE Breckenridge Pharmaceutical, Inc.