Dr Reddy’s Laboratories Ltd has launched Vigabatrin Tablets, a therapeutic equivalent generic version of Sabril (vigabatrin) tablets approved by the US Food and Drug Administration (USFDA).
“We are pleased that this product has been designated as a Competitive Generic Therapy (CGT) by the FDA,” Marc Kikuchi, Chief Executive Officer, North America Generics, Dr Reddy’s Laboratories, said in a release on Tuesday.
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“With a CGT designation, we have 180-day CGT exclusivity to market this product,” he added.
The Sabril brand and generic had US sales of approximately $141 million MAT for the most recent 12 months ending in December 2020, according to IMS Health.