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.

April 01, 2024
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