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Palovarotene
go.drugbank.com/drugs/DB05467Approved[L40010] On August 16, 2023, palovarotene was also approved by the FDA for the management of HO associated with FOP.[L47845] … [L39990,L40020] It has been granted rare pediatric disease and breakthrough therapy designations from the US FDA, although a previously submitted NDA was withdrawn in August 2021 pending the resubmission
Zotepine
go.drugbank.com/drugs/DB09225ApprovedWithdrawn[A31857] Zotepine was never approved by the FDA. … [L1082] When the analysis of antipsychotics was retaken in 2016 by the FDA, zotepine did not reach the threshold effect to be further studied.[L1313].
Reslizumab
go.drugbank.com/drugs/DB06602ApprovedInvestigationalIL-5 is a pro-inflammatory cytokine that is responsible for the growth and differentiation, recruitment, activation, and survival of eosinophils [FDA Label]. … Approved by the FDA in March 2016, reslizumab is marketed under the brand name Cinqair for intravenous injection. It is injected once every four weeks via intravenous infusion.
Rabies immune globulin, human
go.drugbank.com/drugs/DB11603ApprovedIMOGAM Rabies Pasteurized is indicated for post-exposure prophylaxis in persons suspected of exposure to rabies, who have not previously received a complete immunization regimen with a cell culture produced rabies vaccine. Persons previo...
Obeticholic acid
go.drugbank.com/drugs/DB05990ApprovedInvestigational[L34650] Obeticholic acid is currently being considered for FDA approval to treat fibrosis caused by non-alcoholic liver steatohepatitis (NASH). … [A18696,L12633] In May 2021, the FDA updated its prescribing information to contraindicate the use of obeticholic acid in patients with PBC and advanced cirrhosis (e.g. those with portal hypertension or
Human cytomegalovirus immune globulin
go.drugbank.com/drugs/DB13886ApprovedInvestigationalIt contains purified immunoglobulin G (IgG) antibodies targeting cytomegalovirus (CMV)[FDA label].
Miltefosine
go.drugbank.com/drugs/DB09031ApprovedInvestigationalThe CDC has also recommended it as a first line treatment for free-living amebae (FLA) infections such as primary amebic meningoencephalitis and granulomatous amebic encephalitis.
Nafcillin
go.drugbank.com/drugs/DB00607ApprovedInvestigationalA semi-synthetic antibiotic related to penicillin, Naficillin is a narrow-spectrum beta-lactam antibiotic drug. It is a beta-lactamase-resistant penicillin that is indicated for the treatment of Staphylococcal infections caused by strain...
Talazoparib
go.drugbank.com/drugs/DB11760ApprovedInvestigational[L47236] Developed by Pfizer, talazoparib was first approved by the FDA in October 2018 [A260346] and by the EMA in June 2019.[L47296] It was approved by Health Canada in September 2020.
Ergoloid mesylate
go.drugbank.com/drugs/DB01049Approved[L2639]Later in 1991, the mixture of ergoloid mesylates was retaken by Sun Pharmaceutical Industries and approved by the FDA. … [A32914] The mixture of ergoloid mesylate was first developed by Novartis and FDA approved on November 5, 1953, but this specific formulation is now discontinued.