The FDA Has Issued A Complete Response Letter In Response To Eton Pharmaceuticals' Marketing Application For Dehydrated Alcohol Injection For Methanol Poisoning; The Issues Raised Relate Primarily To Chemistry Manufacturing And Controls
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The FDA has issued a complete response letter to Eton Pharmaceuticals' marketing application for its dehydrated alcohol injection for methanol poisoning. The issues raised are primarily related to chemistry manufacturing and controls.
June 28, 2023 | 10:52 am
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Eton Pharmaceuticals' application for its dehydrated alcohol injection has been responded to by the FDA, with issues raised on chemistry manufacturing and controls. This could potentially delay the product's approval and impact the company's stock.
The FDA's response to Eton Pharmaceuticals' application indicates potential issues that could delay the approval of the product. This could impact the company's revenues and thus, its stock price. The company's stock is likely to be negatively affected in the short term due to this news.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100