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Search results for nonoxynol root_names_stdName in Standardized Name (approximate match)
Status:
US Approved Rx
(2023)
Source:
NDA216023
(2023)
Source URL:
First approved in 2023
Source:
NDA216023
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Status:
US Approved Rx
(2023)
Source:
NDA218213
(2023)
Source URL:
First approved in 2023
Source:
NDA218213
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Repotrectinib (TPX-0005) Is a Next-Generation ROS1/TRK/ALK Inhibitor. It represents an effective therapeutic option for patients with ROS1-, NTRK1-3-, or ALK-rearranged malignancies who have progressed on earlier-generation tyrosine kinase inhibitors. In June 2017, The US Food and Drug Administration (FDA) granted orphan drug designation to this drug for the treatment of Non–small cell lung adenocarcinoma with an ALK, ROS1, or NTRK mutation.
Status:
US Approved Rx
(2023)
Source:
NDA217417
(2023)
Source URL:
First approved in 2023
Source:
NDA217417
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Biafungin (formerly SP 3025 or CD101), a highly stable echinocandin and an antifungal drug that was studied against panels of Candida and Aspergillus clinical isolates. Biafungin was involved in phase II clinical trials in the treatment of acute moderate to severe vulvovaginal candidiasis. Seachaid Pharmaceuticals invented this drug. Then Cidara Therapeutics acquired a worldwide exclusive license to develop and commercialize the drug.
Status:
US Approved Rx
(2022)
Source:
NDA216986
(2022)
Source URL:
First approved in 2022
Source:
NDA216986
Source URL:
Class (Stereo):
CHEMICAL (MIXED)
Status:
US Approved Rx
(2021)
Source:
NDA214665
(2021)
Source URL:
First approved in 2021
Source:
NDA214665
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Status:
US Approved Rx
(2020)
Source:
NDA212728
(2020)
Source URL:
First approved in 2020
Source:
NDA212728
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Bristol-Myers Squibb developed Rimegepant, also known as BMS-927711. Rimegepant is a potent, selective, competitive and orally active calcitonin gene-related peptide (CGRP) antagonist in clinical trials for treating migraine. Rimegepant has shown in vivo efficacy without vasoconstrictor effect; it is superior to placebo at several different doses (75 mg, 150 mg, and 300 mg) and has an excellent tolerability profile.
Status:
US Approved Rx
(2020)
Source:
NDA210730
(2020)
Source URL:
First approved in 2020
Source:
NDA210730
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Status:
US Approved Rx
(2020)
Source:
NDA213036
(2020)
Source URL:
First approved in 2020
Source:
NDA213036
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Sodium artesunate, an artemisinin derivative, is used in malaria treatment. Artesunate, has been licensed in Thailand for the
treatment of falciparum malaria since 1990. It is a potent antimalarial drug that can reduce parasitaemia by 90% within 24 h of administration. Sodium artesunate was first isolated in China, it is a water soluble antimalaria used clinically in China.
Status:
US Approved Rx
(2020)
Source:
NDA213702
(2020)
Source URL:
First approved in 2020
Source:
NDA213702
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Lurbinectedin (PM-01183) - is a synthetic tetrahydropyrrolo [4, 3, 2-de]quinolin-8(1H)-one alkaloid analogue with potential antineoplastic activity. Lurbinectedin covalently binds to residues lying in the minor groove of DNA, which may result in delayed progression through S phase, cell cycle arrest in the G2/M phase and cell death. Lurbinectedin is a novel anticancer agent currently undergoing late-stage (Phase II /III) clinical evaluation in platinum-resistant ovarian, BRCA1/2-mutated breast and small-cell lung cancer. Lurbinectedin is structurally related to trabectedin and it inhibits active transcription and the DNA repair machinery in tumour cells.
Status:
US Approved Rx
(2020)
Source:
NDA212489
(2020)
Source URL:
First approved in 2020
Source:
NDA212489
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Opicapone (Ongentys®), a potent, oral, third-generation, long-acting, peripheral catechol-O-methyltransferase (COMT) inhibitor, is approved as the adjunctive treatment to levodopa (L-Dopa)/dopa-decarboxylase inhibitor (DDCI) therapy in adults with Parkinson's disease (PD) and end-of-dose motor fluctuations who cannot be stabilized on those combinations. Opicapone is a hydrophilic 1,2,4-oxadiazole analog with a pyridine N-oxide at position 3, with these modifications enhancing its potency and extending its duration of action, whilst avoiding cell toxicity. In preclinical animal studies, Opicapone-induced inhibition of peripheral (but not central) COMT activity was associated with a prolonged increase in systemic and central exposure to L-Dopa, with a corresponding reduction in 3-OMD exposure. Following single or multiple doses of Opicapone (5–1200 mg) in healthy adult volunteers or patients with PD, Opicapone inhibited COMT activity in ex vivo erythrocyte assays in a reversible dose-dependent manner, with the duration of Opicapone-induced COMT inhibition independent of dose. Adjunctive Opicapone was generally well tolerated during more than a year of treatment in BIPARK I and BIPARK II (double-blind plus extension phases). The recommended dosage is 50 mg once daily, which should be taken at bedtime at least 1 h before or after L-Dopa combinations.