US FDA Disapproves Anti-Seizure Drug ‘Lamotrigine’ of Eton Pharmaceuticals


On Friday, 27th May 2022, Eton Pharmaceuticals Inc. said, the Food and Drug Administration (FDA) of the United States has declined to approve the company’s anti-seizure drug known as lamotrigine, which has sent the shares of the company down by 13 percent in the extended trading.

The company had been notified that, its privately held partner ‘Azurity Pharmaceuticals’ has received a complete response letter from the health regulator of the United States for the drug.

The drug ‘lamotrigine’ had been one of the three drugs in the neurology portfolio of Eton Pharmaceuticals that, the company has sold to Azurity Pharmaceuticals in 2021 for around 45 million dollars in the payments milestone.

The drug of Eton Pharmaceuticals, is a liquid form of a largely available anticonvulsant oral tablet, which is also going by the name called as lamotrigine and it is also helping in stabilizing electrical activity inside the brain of the people and making it more harder for certain neurons for getting stimulated and hence preventing the seizures.

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The company has not revealed the details of the complete response letter and has also added that, it had been assessing the comments of the US FDA along with the partners of the company. Both Eton Pharmaceuticals and Azurity Pharmaceuticals has declined to respond to the requests.