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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 ]
In Europe, the technical document is called the "summary of product characteristics" (SmPC), and the document for end-users is called the "patient information leaflet" (PIL) or "package leaflet". [3] Similar documents attached to the outside of a package are sometimes called outserts. [citation needed]
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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An estimated 10–20% of NSAID patient's experience dyspepsia, and NSAID-associated upper gastrointestinal adverse events are estimated to result in 103,000 hospitalizations and 16,500 deaths per year in the United States, and represent 43% of drug-related emergency visits. Many of these events are avoidable; a review of physician visits and ...
Ofatumumab is a fully human monoclonal antibody to CD20, which appears to provide rapid B-cell depletion. [13] Under the brand name Kesimpta, it is approved for the treatment of multiple sclerosis in the United States as well as in the European Union and other regions.
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