Amneal intros generic Sabril for oral solution

5/3/2018
Amneal Pharmaceuticals has introduced its generic of Lundbeck’s Sabril (vigabatrin for oral solution). The drug is indicated to refractory complex partial seizures in patients who have not responded well enough to other treatments in patients ages 10 years and older, as well as for infantile spasms in babies one month to 2 years old.

Amneal’s generic Sabril is the second on the market. It is available in cartons of 50 packets each containing 500-mg of the drug. The Bridgewater, N.J.-based company said it also is pursuing a generic of the tablet form of the product.

“We are pleased to add this critical specialty product to our catalog,” said Andy Boyer, Amneal executive vice president of commercial operations.  “Bringing a second generic option to this small patient population exemplifies our commitment to delivering products with value to patients and the healthcare system.”

The generic Sabril was approved under a Risk Evaluation and Mitigation Strategy called the Vigrabatrin REMS program.

The product had a U.S. market size of roughly $318 million for the 12 months ended in March, according to IQVIA data.

 
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