Full Press Release Details
Pharmaceuticals Receives Complete Response Letter from U.S. FDA for Dehydrated Alcohol Injection
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 is 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.
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.
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.