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Apremilast, sold under the brand name Otezla among others, is a medication for the treatment of certain types of psoriasis and psoriatic arthritis. [4] The drug acts as a selective inhibitor of the enzyme phosphodiesterase 4 (PDE4). [ 4 ]
Each country or region has their own regulatory body. In the European Union, the European Medicines Agency has jurisdiction and the relevant documents are called the "summary of product characteristics" (SPC or SmPC) and the document for end-users is called the "patient information leaflet" or "package leaflet".
Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book, is a publication produced by the United States Food and Drug Administration (FDA), as required by the Drug Price and Competition Act (Hatch-Waxman Act). The Hatch-Waxman Act was created to '"strike a balance between two competing policy interests:
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The FDA approved Bristol Myers Squibb Co's (NYSE: BMY) Sotyktu (deucravacitinib), an allosteric tyrosine kinase 2 (TYK2) inhibitor, for moderate-to-severe plaque psoriasis who are candidates for ...
FDA Building 51 is one of the main buildings in its White Oak campus that houses the Center for Drug Evaluation and Research. The Center for Drug Evaluation and Research (CDER, pronounced "see'-der") is a division of the U.S. Food and Drug Administration (FDA) that monitors most drugs as defined in the Food, Drug, and Cosmetic Act.
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