ACTIVE SUBSTANCE / INN

PEMETREXED

Brand name(s): Pemetrexed ditromethamine Hospira, Alimta, Pemetrexed Accord, Pemetrexed Pfizer (previously Pemetrexed Hospira UK Limited), Pemetrexed medac, PEMETREXED, Armisarte (previously Pemetrexed Actavis), Ciambra, Pemetrexed Krka, Pemetrexed Fresenius Kabi, PEMETREXED FOR INJECTION, Pemetrexed Lilly, Pemetrexed Sandoz, PEMFEXY, Pemetrexed Baxter, Pemetrexed Pfizer (previously Pemetrexed Hospira), ALIMTA
FDA LISTED
EMA LISTED
PRESCRIPTION
WITHDRAWN
APPLICATION WITHDRAWN
ANDA208927
Carcinoma, Non-Small-Cell Lung;Mesothelioma
ACTIVE SUBSTANCE
Pemetrexed
REGULATORS
FDA · EMA
SPONSORS / MAH
KRKA d.d., ACTAVIS, EAGLE PHARMS
TOTAL APPLICATIONS
18
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
PEMETREXEDNDA208419ACTAVISPrescription
PEMFEXYNDA209472EAGLE PHARMSPrescription
PEMETREXED FOR INJECTIONNDA208297DR REDDYS LABS INCPrescription
PEMETREXEDANDA208927BIOCON LTDNone (Tentative Approval)
ALIMTANDA021677LILLYPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
Pemetrexed AccordAccord Healthcare S.L.U.Authorised18/01/2016Carcinoma, Non-Small-Cell Lung;Mesothelioma
AlimtaEli Lilly Nederland B.V.Authorised20/09/2004Mesothelioma;Carcinoma, Non-Small-Cell Lung
Pemetrexed Pfizer (previously Pemetrexed Hospira)Pfizer Europe MA EEIGAuthorised19/11/2015Carcinoma, Non-Small-Cell Lung;Mesothelioma
Armisarte (previously Pemetrexed Actavis)Actavis Group PTC ehfAuthorised18/01/2016Carcinoma, Non-Small-Cell Lung;Mesothelioma
Pemetrexed medacmedac Gesellschaft für klinische Spezialpräparate mbHAuthorised26/11/2015Carcinoma, Non-Small-Cell Lung;Mesothelioma
Pemetrexed Fresenius KabiFresenius Kabi Deutschland GmbHAuthorised22/07/2016Carcinoma, Non-Small-Cell Lung;Mesothelioma
Pemetrexed SandozSandoz GmbHWithdrawn18/09/2015Carcinoma, Non-Small-Cell Lung;Mesothelioma
CiambraMenarini International Operations Luxembourg S.A.Withdrawn02/12/2015Carcinoma, Non-Small-Cell Lung;Mesothelioma
Pemetrexed KrkaKRKA d.d.Withdrawn22/05/2018Carcinoma, Non-Small-Cell Lung;Mesothelioma
Pemetrexed BaxterBaxter Holding B.V.Authorised09/12/2022Carcinoma, Non-Small-Cell Lung;Mesothelioma

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