Complete Response Letter for lamotrigine liquid oral tablet for Epilepsy.
Eton Pharma announced that the FDA declined to approve its anti-seizure drug lamotrigine.
Eton was notified that its privately held partner Azurity Pharma received a complete response letter from the health regulator for lamotrigine, it said in a regulatory filing.
Lamotrigine was one of the three drugs in Eton’s neurology portfolio that Eton sold to Azurity Pharma last year for up to $45 million in milestone payments. The drug is a liquid form of a widely available anti-convulsant or anti-epileptic oral tablet, which also goes by the name lamotrigine. It helps stabilise electrical activity inside the brain and makes it harder for certain neurons to get stimulated, thus preventing seizures.
Eton did not disclose the details of the complete response letter and added that it was assessing the FDA’s comments along with its partner.
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