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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 ]
Amgen presented results from the Phase 3 ADVANCE trial of Otezla in patients with plaque psoriasis at the American Academy of Dermatology Virtual Meeting Experience 2021. In the placebo-controlled ...
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.
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". The SPC is not intended to give general advice about treatment of a condition but does ...
Based on an evaluation of the potential safety concern, The FDA may take regulatory action(s) to improve product safety and protect the public health, such as updating a product's labeling information, restricting the use of the drug, communicating new safety information to the public, or, in rare cases, removing a product from the market.
Under the act, supplements are regulated by the FDA for Good Manufacturing Practices under 21 CFR Part 111. [2] The act was intended to exempt the dietary and herbal supplement industry from most FDA drug regulations, allowing them to be sold and marketed without scientific backing for their health and medical claims. [3]
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