Eton handed second CRL for methanol poisoning treatment

The FDA is­sued its sec­ond com­plete re­sponse let­ter to Eton Phar­ma­ceu­ti­cals for its treat­ment to counter methanol poi­son­ing, which oc­curs from in­gest­ing house­hold prod­ucts like an­tifreeze and var­nish.

Eton said Wednes­day in a re­lease that the CRL is “pri­mar­i­ly” re­lat­ed to chem­istry man­u­fac­tur­ing and con­trols for its de­hy­drat­ed al­co­hol in­jec­tion. It did not share any ad­di­tion­al de­tails. The Deer­park, IL-based phar­ma said all of the is­sues raised by the FDA can be ad­dressed, and it’s work­ing on an ac­tion plan.

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