FDA hands a CRL to drugmaker Eton after a delayed inspection — but are Covid-19 travel restrictions really the issue?
For the second time in three years, Eton Pharmaceuticals has received a complete response letter from the FDA, this time for its dehydrated alcohol injection to treat methanol poisoning. The company blamed the delay on a missing inspection but also pointed to “other questions” from the agency.
On Friday, Eton disclosed it had received a letter from the agency, tying it to a pending pre-approval inspection of its European manufacturer due to Covid-related travel restrictions. But it’s worth noting that the FDA doesn’t issue CRLs based solely on inspection delays, an agency spokesman previously told Endpoints News, indicating there may have been other issues with Eton’s application.
“The company believes all other FDA questions raised in the letter can be fully addressed in a response in the coming months,” the company said in a release. A spokesman could not be reached at press time.
Wall Street responded accordingly to the news, sending Eton’s stock down as much as 14% shortly after the opening bell Friday.
In 2019, Eton’s plan to launch an over-the-counter treatment for an ocular itch often found in children was also issued a CRL. The eye drop — now dubbed Alaway — set out to be the first preservative-free allergy eye drop in the US. A year later, the drops cleared the FDA.
Eton currently receives royalties from three FDA-approved products, including Alaway. Alkindi Sprinkle is a corticosteroid used for benign adrenocortical tumors in children. Eton acquired the Canadian rights to Alkindi Sprinkle at the start of the year. Biorphen, when approved in 2019, became the first ready-to-use form of phenylephrine for the treatment of hypotension from anesthesia.
The company sold its neurology portfolio — which includes epilepsy seizure drug zonisamide — to Azurity Pharmaceuticals in February for $15 million upfront, in a deal worth up to $45 million total.
Social: Sean Brynjelsen, Eton CEO (file photo)