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Sol-Gel’s Collaboration Partner First-to-File ANDA Drug Product Generic to Zoryve® Cream.
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.
The drug is indicated for treating plaque psoriasis in patients six years and older.
However, Arcutis Biotherapeutics, a competitor, has initiated a patent infringement action against Padagis.
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El socio colaborador de Sol-Gel es el primero en presentar un medicamento genérico de ANDA para Zoryve® Cream.