This site is intended for healthcare professionals
Latest drug news
  • Home
  • /
  • News
  • /
  • 2021
  • /
  • 5
  • /
  • Eton Pharmaceuticals receives complete response le...
News

Eton Pharmaceuticals receives complete response letter from FDA for dehydrated alcohol injection for the treatment of methanol poisoning.

Read time: 1 mins
Published:30th May 2021
Eton Pharmaceuticals, Inc., has announced that the company has received a Complete Response Letter (CRL) from the FDA in response to the submission of its New Drug Application (NDA) for dehydrated alcohol injection for the treatment of methanol poisoning.

The CRL indicated that the FDA has completed its review of the application and has determined that the application cannot be approved in its present form. A Pre-Approval Inspection (PAI) of the product’s European contract manufacturer is pending due to what the company believes are COVID-related travel restrictions. The company believes all other FDA questions raised in the letter can be fully addressed in a response in the coming months.

Condition: Methanol Poisoning
Type: drug

Learning Zones

The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.