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Mögliche FDA Genehmigung morgen für EM-100: EM-100, Eton’s preservative-free ophthalmic solution for allergic conjunctivitis has been assigned a target action date of July 11, 2019. EM-100 Ophthalmic Solution •Innovative over-the-counter ophthalmic solution for treatment of allergic conjunctivitis •If approved, EM-100 would be the first preservative-free ophthalmic product indicated for allergic conjunctivitis •Product has been filed with the FDA and is expected to be approved in 2019 •U.S. allergic conjunctivitis ophthalmic market is >$600 million annually •Eton partnered with Bausch Health for commercialization •Eton receives additional milestone payment upon approval and a royalty on net sales |
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| aus der Diskussion: | ETON (Mkap $133 M) 3x FDA-Entscheide + Multiple NDA-Anträge in kürze |
| Autor (Datum des Eintrages): | Zenobia (10.07.19 17:34:35) |
| Beitrag: | 25 von 309 (ID:60997112) |
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