Hulskof schreef op 19 februari 2020 14:11:
Vertraging bij Eton:
Eton Pharmaceuticals Provides Update on ET-105 Program
DEER PARK, Ill., Feb. 19, 2020 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (Nasdaq: ETON), a specialty pharmaceutical company focused on developing and commercializing innovative drug products, today provided an update on its ET-105 product candidate, which is currently under review with the U.S. Food and Drug Administration (FDA).
In a review correspondence and a teleconference held yesterday, the FDA requested that Eton and its development partner make changes to the Dosage and Administration section of the product’s Prescribing Information to simplify the dosing information for intended users. The FDA has requested that the company conduct a human factors validation study with the revised labeling to demonstrate that the intended users can prepare and administer the oral suspension safely and effectively. Eton remains confident that it can successfully complete the requested human factors validation study, however,
the study is unlikely to be completed by the product’s March 17, 2020 Prescription Drug User Fee Act date. The company expects the study and its final report to be completed and submitted to the FDA in the coming months. Eton is not aware of any other non-labeling related deficiencies outstanding with the FDA’s review and believes the NDA will be approved in 2020.
ir.etonpharma.com/news-releases/news-...