Eton Pharmaceuticals Receives Complete Response Letter from U.S. FDA for Dehydrated Alcohol Injection

Rhea-AI Summary

Eton Pharmaceuticals, Inc. (Nasdaq: ETON) has received a Complete Response Letter (CRL) from the FDA concerning its New Drug Application for dehydrated alcohol injection used in treating methanol poisoning. The FDA's review concluded the application cannot be approved in its current form. A Pre-Approval Inspection of the European manufacturer is pending due to COVID-related travel restrictions. Eton anticipates addressing all FDA queries in a forthcoming response.

Positive

• Eton owns or receives royalties from three FDA-approved products.
• The company has six additional products submitted to the FDA.

Negative

• The FDA's CRL indicates that the current NDA cannot be approved.
• Pending Pre-Approval Inspection due to COVID-related travel restrictions.

DEER PARK, Ill., May 28, 2021 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (Nasdaq: ETON), today announced that the company has received a Complete Response Letter (CRL) from the U.S. Food & Drug Administration (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.

About Eton Pharmaceuticals
Eton Pharmaceuticals, Inc. is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. The company currently owns or receives royalties from three FDA-approved products, including ALKINDI^® SPRINKLE, Biorphen^®, and Alaway Preservative Free^®, and has six additional products that have been submitted to the FDA.

Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements associated with the expected ability of Eton to undertake certain activities and accomplish certain goals and objectives. These statements include but are not limited to statements regarding Eton’s business strategy, Eton’s plans to develop and commercialize its product candidates, the safety and efficacy of Eton’s product candidates, Eton’s plans and expected timing with respect to regulatory filings and approvals, and the size and growth potential of the markets for Eton’s product candidates. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Eton’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. These and other risks concerning Eton’s development programs and financial position are described in additional detail in Eton’s filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Eton undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Company Contact:
David Krempa
dkrempa@etonpharma.com
612-387-3740

 

FAQ

What is the significance of the Complete Response Letter for Eton Pharmaceuticals' NDA for dehydrated alcohol injection?

The Complete Response Letter indicates that Eton's New Drug Application cannot be approved in its current form, requiring further actions to address FDA concerns.

What products does Eton Pharmaceuticals currently have approved by the FDA?

Eton currently owns or receives royalties from three FDA-approved products: ALKINDI® SPRINKLE, Biorphen®, and Alaway Preservative Free®.

How many products has Eton Pharmaceuticals submitted to the FDA?

Eton Pharmaceuticals has submitted six additional products to the FDA for approval.

What challenges is Eton Pharmaceuticals facing with its NDA for dehydrated alcohol injection?

Eton is facing challenges due to the FDA's Complete Response Letter and pending Pre-Approval Inspection related to COVID-19 travel restrictions.

What potential impacts could the FDA's CRL have on Eton Pharmaceuticals' stock?

The FDA's CRL can lead to investor concerns regarding the timelines for product approvals, potentially impacting Eton's stock performance.