Eton Pharmaceuticals Announces FDA Acceptance of New Drug Application for ET-600 (Desmopressin Oral Solution)
- NDA assigned a Target Action Date of
- Product has patent protection through 2044 -
“We are thrilled to be one step closer to bringing ET-600 to patients and addressing another significant unmet need within the pediatric endocrinology community. Currently, caregivers are often forced to cut fractional tablets or use unapproved liquid suspensions from compounding pharmacies to accommodate the precise, titratable doses required to treat pediatric patients. If approved, ET-600 is expected to be the only oral liquid option on the market, providing a much-needed avenue for delivering accurate doses for children,” said
About ET-600
ET-600 is a proprietary formulation of desmopressin oral solution developed for the treatment of central diabetes insipidius, also known as arginine vasopressin deficiency (AVP-D). The company has been issued a patent for ET-600’s formulation that extends to 2044 and has an additional patent application under review by the United States Patent and Trademark Office. AVP-D is estimated to impact approximately 3,000 pediatric patients in
About
Eton is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. The Company currently has eight commercial rare disease products: KHINDIVI™, INCRELEX®, ALKINDI SPRINKLE®, GALZIN®, PKU GOLIKE®, Carglumic Acid, Betaine Anhydrous, and Nitisinone. The Company has five additional product candidates in late-stage development: ET-600, Amglidia®, ET-
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
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Source:
Source: Eton Pharmaceuticals