Sol-Gel 的合作伙伴首次申请 ANDA 药品仿制药 Zoryve® Cream。 Sol-Gel’s Collaboration Partner First-to-File ANDA Drug Product Generic to Zoryve® Cream.
Sol-Gel Technologies (SLGL) 合作伙伴 Padagis Israel Pharmaceuticals 已向美国 FDA 提交了一份关于 Roflumilast Cream 0.3%(Zoryve Cream 的仿制药)的首次提交的简化新药申请 (ANDA)。 Sol-Gel Technologies (SLGL) partner, Padagis Israel Pharmaceuticals, has submitted a first-to-file Abbreviated New Drug Application (ANDA) to the U.S. FDA for Roflumilast Cream 0.3%, a generic version of Zoryve Cream. 该药物适用于治疗六岁及以上患者的斑块状银屑病。 The drug is indicated for treating plaque psoriasis in patients six years and older. 然而,其竞争对手Arcutis Biotherapeutics已对Padagis发起专利侵权诉讼。 However, Arcutis Biotherapeutics, a competitor, has initiated a patent infringement action against Padagis.