Record mula sa primary source
Decision-gradePag-apruba ng FDA
Eton Pharmaceuticals: Inaprubahan ng FDA ang DESMODA (desmopressin) Oral Solution
Inaprubahan ng FDA ang NDA para sa DESMODA (desmopressin acetate) Oral Solution noong Pebrero 25, 2026. Saklaw ng pag-apruba ang antidiuretic replacement therapy para sa central diabetes insipidus/AVP-D sa mga pasyente ng lahat ng edad. Ang produkto ay naaprubahan na para sa komersyal na paglulunsad sa U.S.
Mahahalagang fact
- Na-file
- Peb 25, 2026, 07:18 PM
- Kaganapan
- Pag-apruba ng FDA
- Direksyon
- Positibo
- Kumpanya
ETONEton Pharmaceuticals- Asset
- desmopressin acetate
- Pinagmulan
- SEC 8-K
- Kumpiyansa
- May source
Sipi mula sa source
eton20260223_8k.htm false 0001710340 0001710340 2026-02-25 2026-02-25 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 February 25, 2026 Date of Report (Date of earliest event reported) ETON PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 001-38738 37-1858472 (State of (Commission (I.R.S. Employer incorporation) File Number) Identification Number) 21925 W. Field Parkway, Suite 235 Deer Park , Illinois 60010 -7278 (Address of principal executive offices) (Zip code) ( 847 ) 787-7361 (Registrant ’ s telephone number, including area code) Check the appropriate box below if the Form 8-K filing is intended to simul