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Submitted URL: https://e.endpointsnews.com/t/t-l-zirujjy-wdkidktkr-b/
Effective URL: https://endpts.com/eton-handed-second-crl-for-methanol-poisoning-treatment/
Submission: On June 28 via api from US — Scanned from DE

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June 28, 2023 10:38 AM EDT
R&D
FDA+


ETON HAND­ED SEC­OND CRL FOR METHANOL POI­SON­ING TREAT­MENT


TYLER PATCHEN

NEWS REPORTER

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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Eton’s stock $ETON fell about 15% on Wednes­day morn­ing. Eton did not
im­me­di­ate­ly re­spond to a re­quest for com­ment.

Back in 2021, the same prod­uct re­ceived a CRL. Eton said at the time that it
was tied to a pend­ing pre-ap­proval in­spec­tion at its Eu­ro­pean
man­u­fac­tur­er due to de­lays from Covid-19 trav­el re­stric­tions. In 2019,
Eton was al­so giv­en a CRL for its over-the-counter oc­u­lar itch treat­ment as
well, but the is­sues were cleared the fol­low­ing year.




AUTHOR


TYLER PATCHEN

NEWS REPORTER

tpatchen@endpointsnews.com @TPatchenendpts
Tyler Patchen on LinkedIn


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Bioscience & Technology Business Center
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