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Efbemalenograstim alfa
go.drugbank.com/drugs/DB18704ApprovedInvestigationalThis approval was contingent on positive results observed in two pivotal Phase 3 Studies GC-627-04 and GC-627-05 in the US and Europe respectively.[L48887]
Tauroursodeoxycholic acid
go.drugbank.com/drugs/DB08834ApprovedInvestigationalWithdrawn[A249080] Tauroursodeoxycholic acid is currently used in Europe to treat and prevent gallstones as a bile acid derivative.
Abetimus
go.drugbank.com/drugs/DB06662InvestigationalAbetimus was developed by La Jolla Pharmaceuticals as an immunosuppressant but was never marketed in American or Europe despite application for marketing authorization in the mid-2000s.
Inotuzumab ozogamicin
go.drugbank.com/drugs/DB05889ApprovedInvestigational[A20352] Inotuzumab ozogamicin was first approved by the European Commission in June 2017 for the treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
Zotepine
go.drugbank.com/drugs/DB09225ApprovedWithdrawn[A31855] It has been used as an antipsychotic in Japan, India and some places in Europe like UK and Germany since 1980's.[A31857] Zotepine was never approved by the FDA.
Desvenlafaxine
go.drugbank.com/drugs/DB06700ApprovedInvestigational[L6016,A261271] MDD is a highly prevalent psychiatric disorder, with a lifetime prevalence estimate of 16% in the US alone and 12.8% in Europe.
ALTU-135
go.drugbank.com/drugs/DB05330InvestigationalALTU-135, the Company's orally administered enzyme replacement therapy for patients with pancreatic insufficiency, is manufactured by blending three drug substance enzymes: lipase, protease and amylase. This consistent and pure enzyme co...
Gabapentin
go.drugbank.com/drugs/DB00996ApprovedInvestigational[A14097,A186179] Gabapentin has some stark advantages as compared with other anti-epileptics, such as a relatively benign adverse effect profile, wide therapeutic index, and lack of appreciable metabolism
Lacosamide
go.drugbank.com/drugs/DB06218ApprovedInvestigational[A262681] Lacosamide was first approved by the European Commission in August 2008 and was later approved by the FDA in October 2008.
Lonapegsomatropin
go.drugbank.com/drugs/DB16220ApprovedInvestigational[L36380] It was later approved by the European Commission on 13 January 2022.[L39900]