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Search results for apremilast in Display Name (approximate match)
Status:
US Approved Rx
(2024)
Source:
ANDA211734
(2024)
Source URL:
First approved in 2014
Source:
NDA205437
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Apremilast (brand name Otezla) selective inhibitor of phosphodiesterase 4 is used for the treatment of patients with moderate to severe plaque psoriasis. OTEZLA is the first and only PDE4 inhibitor approved for the treatment of plaque psoriasis, a chronic inflammatory disease of the skin resulting from an uncontrolled immune response. Apremilast also inhibits spontaneous production of TNF-alpha from human rheumatoid synovial cells. It has anti-inflammatory activity. By inhibiting PDE-4, apremilast increases intracellular levels of cAMP and thereby inhibits the production of multiple proinflammatory mediators including PDE-4, TNF-alpha, interleukin-2 (IL-2), interferon-gamma, leukotrienes, and nitric oxide synthase.
Status:
Designated
Source:
FDA ORPHAN DRUG:622417
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
APREMILAST, (±)- is a mixture of isomers, one of them is therapeutic active S form (apremilast), an inhibitor of phosphodiesterase 4. This active form is sold under the brand name OTEZLA for the treatment of adult patients with active psoriatic arthritis.