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ACTIVE SUBSTANCE / INN

APREMILAST

Brand name(s): OTEZLA, APREMILAST, Apremilast Viatris, OTEZLA XR, Apremilast Accord, Otezla
FDA LISTED
EMA LISTED
DISCONTINUED
PRESCRIPTION
APPLICATION WITHDRAWN
NDA205437
NDA210745
ACTIVE SUBSTANCE
Apremilast
REGULATORS
FDA · EMA
SPONSORS / MAH
DR REDDYS, MANKIND PHARMA, ZYDUS PHARMS
TOTAL APPLICATIONS
8
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
APREMILASTANDA211859ZYDUS PHARMSNone (Tentative Approval)
APREMILASTANDA211734MANKIND PHARMAPrescription
OTEZLANDA205437AMGEN INCPrescription
APREMILASTANDA211756DR REDDYSDiscontinued
OTEZLA XRNDA210745AMGEN INCPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
OtezlaAmgen Europe B.V.Authorised15/01/2015Arthritis, Psoriatic;Psoriasis;Behcet Syndrome
Apremilast AccordAccord Healthcare S.L.U.Authorised19/04/2024Arthritis, Psoriatic;Psoriasis;Behcet Syndrome;Oral Ulcer
Apremilast ViatrisViatris LimitedApplication withdrawnArthritis, Psoriatic;Psoriasis;Behcet Syndrome

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