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Search results for beta root_references_citation in Reference Text / Citation (approximate match)
Status:
Possibly Marketed Outside US
Source:
21 CFR 348
(2014)
Source URL:
First approved in 2012
Source:
21 CFR 352
Source URL:
Class:
STRUCTURALLY DIVERSE
Status:
Possibly Marketed Outside US
Source:
21 CFR 352
(2023)
Source URL:
First approved in 2011
Source:
M016
Source URL:
Class:
STRUCTURALLY DIVERSE
Status:
Possibly Marketed Outside US
Source:
21 CFR 352
(2012)
Source URL:
First approved in 2010
Source:
21 CFR 333D
Source URL:
Class:
STRUCTURALLY DIVERSE
Status:
First approved in 2004
Source:
21 CFR 358H
Source URL:
Class:
STRUCTURALLY DIVERSE
Status:
Possibly Marketed Outside US
First approved in 1987
Source:
21 CFR 341
Source URL:
Class:
STRUCTURALLY DIVERSE
Status:
Other
Class:
G1 SPECIFIED SUBSTANCE
Status:
Designated
Source:
FDA ORPHAN DRUG:883922
Source URL:
Class:
CONCEPT
Status:
US Approved Rx
(2023)
Source:
ANDA214008
(2023)
Source URL:
First approved in 2015
Source:
NDA207981
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Tipiracil is a thymidine phosphorylase inhibitor, that used for the treatment of patients with metastatic colorectal cancer. Tipiracil is used in combination with trifluridine as Lonsurf. Trifluridine is incorporated into DNA via phosphorylation, ultimately inhibiting cell proliferation. Tipiracil increases systemic exposure of trifluridine when coadministered. Lonsurf has recently been approved for the treatment of adult patients with metastatic colorectal cancer (mCRC) who are refractory to or are not considered candidates for, current standard chemotherapy and biological therapy in the EU and USA and in unresectable advanced or recurrent CRC in Japan. The approved regimen of oral twice-daily Lonsurf significantly improved overall survival and progression-free survival and was associated with a significantly higher disease control rate than placebo when added to best supportive care in the multinational, pivotal phase III trial (RECOURSE) and a phase II Japanese trial. Trifluridine/tipiracil was associated with an acceptable tolerability profile, with adverse events generally being managed with dose reductions, temporary interruptions in treatment or administration of granulocyte-colony
stimulating factor. The most common grade 3–4 adverse events (>10 %) were anemia, neutropenia, thrombocytopenia, and leukopenia.
Status:
US Approved Rx
(2017)
Source:
NDA209482
(2017)
Source URL:
First approved in 2013
Source:
NDA203975
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Umeclidinium (used as a bromide salt) is a long-acting, antimuscarinic antagonist, often referred to as an anticholinergic, developed for the treatment of chronic obstructive pulmonary disease (COPD) (alone and in combination with Vilanterol - long-acting beta2-adrenergic agonist). Umeclidinium has similar affinity to the subtypes of muscarinic receptors M1 to M5 with Ki values of 0.16 nM, 0.15 nM, 0.06 nM, 0.05 nM and 0.13 nM for M1, M2, M3, M4 and M5, respectively. Umeclidinium is selective against mAChR over other unrelated receptors or channels such as κ and σ opiod receptors, Na+ channel and dopamine transporter. In the airways, it exhibits pharmacological effects through the inhibition of M3 receptor at the smooth muscle leading to bronchodilation. There is potential for an additive interaction with concomitantly used anticholinergic medicines.
Status:
US Approved Rx
(2024)
Source:
ANDA218770
(2024)
Source URL:
First approved in 1999
Source:
XOPENEX by HIKMA
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Targets:
Levalbuterol is the (R)-enantiomer of the drug substance racemic albuterol (salbutamol). Binding studies have demonstrated that (R)-albuterol binds to the beta2-adrenergic receptor with a high affinity, whereas (S)-albuterol binds with 100-fold less affinity than (R)-albuterol. Other evaluations have suggested that (R)-albuterol possesses the bronchodilatory, bronchoprotective, and ciliary-stimulatory properties of racemic albuterol, while (S)-albuterol does not contribute beneficially to the therapeutic effects of the racemate and was originally assumed to be inert. Xopenex (levalbuterol HCl) Inhalation Solution is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease.