Amneal Launches Generic for Sabril®: Vigabatrin for Oral Solution, USP

May 2, 2018

Bridgewater, NJ (USA), May 2, 2018 - 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,” states Amneal EVP-Commercial Operations Andy Boyer. “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 US FDA 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. Information on this program is available at or 866-244-8175.

Click here to view full prescribing information for vigabatrin.

About Amneal

Amneal Pharmaceuticals LLC, a privately-held company headquartered in Bridgewater, New Jersey, is one of the largest and the fastest growing generics pharmaceutical manufacturers in the United States. Founded in 2002, Amneal now has more than 5,000 employees in North America, Asia and Europe, working together to bring high quality affordable medicines to patients worldwide. Amneal has significantly expanded its portfolio of generic products to include complex dosage forms in a broad range of therapeutic areas.

Amneal Pharmaceuticals LLC and Impax Laboratories, Inc. (NASDAQ: IPXL) announced on October 17, 2017 that they have entered into a definitive business combination agreement with the resulting combined company expected to create the 5th largest generics business (by gross revenue) in the United States. The transaction is expected to close in the first half of 2018.

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Andy Boyer
Executive Vice President, Commercial Operations

Cheryl Lechok
Media Relations

Business Development
Apurva Saraf
Vice President, Global Strategy & Corporate Development