BRIDGEWATER, N.J. — Amneal Pharmaceuticals has launched vigabatrin for oral solution USP, a generic equivalent for Sabril. This is the second generic vigabatrin product currently on the market. Each carton contains fifty 500 mg packets. The finished dosage form is manufactured in the United States.
“We are pleased to add this critical, specialty product to our catalog,” Amneal executive vice president – commercial operations Andy Boyer said in a statement. “Bringing a second generic option to this small patient population exemplifies our commitment to delivering products with value to patients and the healthcare system.”
Amneal has also filed an ANDA with U.S. Food and Drug Administration for the tablet form of vigabatrin.
Annual U.S. sales of vigabatrin for oral solution (brand and generic) were $318 million, according to March 2018 IQVIA market data.
The Amneal generic product received FDA approval under a Risk Evaluation and Mitigation Strategy (REMS) known as the Vigabatrin REMS program.