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Edaravone
go.drugbank.com/drugs/DB12243ApprovedInvestigational[L44007] The oral suspension formulation of edaravone was approved by the FDA in May 2022 and by Health Canada in November 2022. … [L44007] It was later approved for the treatment of amyotrophic lateral sclerosis (ALS) in Japan and South Korea in 2015, followed by the FDA approval in May 2017 [L41810] and Health Canada approval in
Onasemnogene abeparvovec
go.drugbank.com/drugs/DB15528ApprovedInvestigational[Nusinersen] is another gene therapy that is currently approved by the FDA for the treatment of SMA in pediatric and adult patients. … Onasemnogene abeparvovec is an adeno-associated virus vector-based gene therapy that has been approved by the FDA in May 2019 for the treatment of infant patients (less than 2 years of age) with spinal
Bebtelovimab
go.drugbank.com/drugs/DB16755ApprovedWithdrawn[L40328] Bebtelovimab was issued an emergency use authorization (EUA) by the FDA on February 11, 2022, for the treatment of mild-to-moderate COVID-19 in select patients. … [L40313] In November 2022, the FDA updated the Health Care Provider Fact Sheet for bebtelovimab to inform of its expected reduced activity against certain emerging Omicron subvariants of SARS-CoV-2.
Denosumab
go.drugbank.com/drugs/DB06643ApprovedInvestigational[A263066] Denosumab was approved by the FDA approved on June 2010 for the treatment of osteoporosis in postmenopausal women. … Two denosumab biosimilars—Wyost® (denosumab-bbdz) [L53063] and Jubbonti® (denosumab-bbdz)[L53058]—were approved by the FDA in March 2024 for all indications of the reference products Xgeva® and Prolia®
International brands: RanmarkFlotufolastat F-18
go.drugbank.com/drugs/DB17851ApprovedInvestigational[L46731,L46737] This is the first FDA-approved, PSMA-targeted imaging agent developed with proprietary radiohybrid (rh) technology. … [A259846] In May 2023, the FDA approved the use of flotufolastat F-18 for PET of PSMA-positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive
Pantothenic acid
go.drugbank.com/drugs/DB01783ApprovedInvestigationalNutraceuticalVet approvedPantothenic acid, also called pantothenate or vitamin B5 (a B vitamin), is a water-soluble vitamin discovered by Roger J. Williams in 1919. For many animals, pantothenic acid is an essential nutrient as it is required to synthesize coenz...
Mixtures: BiO-LiFE Anti-FR+Selenium Tablets, Nephron FADapoxetine
go.drugbank.com/drugs/DB04884InvestigationalIn October 2005, the company received a FDA Non-Approvable letter from the FDA, at which time they planned to work with regulators to address outstanding questions. … Alza submitted a NDA to the FDA for dapoxetine for the treatment of premature ejaculation in December 2004.
Telmisartan
go.drugbank.com/drugs/DB00966ApprovedInvestigationalTelmisartan is an angiotensin II receptor antagonist (ARB) used in the management of hypertension. Generally, angiotensin II receptor blockers (ARBs) such as telmisartan bind to the angiotensin II type 1 (AT1) receptors with high affinit...
Mixtures: Nra-telmisartan/hctz, Nra-telmisartan/hctzProducts: Nra-telmisartanPregabalin
go.drugbank.com/drugs/DB00230ApprovedInvestigational[A187190] Although as per the FDA Label the mechanism of action has not been definitively characterized, there is evidence that pregabalin exerts its effects by binding to the α2δ subunit of voltage-dependent
Products: Nra-pregabalinBenzatropine
go.drugbank.com/drugs/DB00245ApprovedInvestigational[A37914] Benztropine was developed by USL Pharma and officially approved by the FDA on 1996.[L5500]