{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
{{facet.count}}
Search results for "ATC|VARIOUS" in comments (approximate match)
Status:
US Approved Rx
(2020)
Source:
NDA212155
(2020)
Source URL:
First approved in 2020
Source:
NDA212155
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Fluoroestradiol F-18 is a derivative of estradiol. where hydrogen at position 16 is replaced by radioactive fluorine. Fluoroestradiol F-18 is taken up by tumor cells, expression estrogen receptor, and it is clinically evaluated for PET imaging to detect and stage breast cancer, ovarian cancer, and cancer of uterine endometrium and myometrium.
Status:
US Approved Rx
(2019)
Source:
NDA210828
(2019)
Source URL:
First approved in 2019
Source:
NDA210828
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Gallium edotreotide Ga-68 is a radioconjugate consisting of the octreotide derivative edotreotide labeled with gallium 68 (Ga-68). Similar to octreotide, gallium Ga 68-edotreotide binds to somatostatin receptors (SSTRs), especially type 2 receptors, present on the cell membranes of many types of neuroendocrine tumor cells and their metastases, thereby allowing for imaging of SSTR-expressing cells with positron emission tomography (PET). Gallium edotreotide Ga-68 has been authorized in the EU as SomaKit for the diagnosis of gastro-entero-pancreatic neuroendocrine tumors. It was investigated in clinical trials for imaging of brain tumors, pituitary tumors and neuroendocrine tumors of various origin.
Status:
US Approved Rx
(2019)
Source:
NDA200655
(2019)
Source URL:
First approved in 2019
Source:
NDA200655
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Fluorodopa F-18 is the amino acid analog fluorodopa (FDOPA) labeled with fluorine F 18, a positron-emitting isotope. It is diagnostic PET agent, which has been used for decades in imaging the loss of dopaminergic neurons in Parkinson's disease, and more recently to detect, stage and restage neuroendocrine tumours and to search for recurrence of viable glioma tissue. Fluorodopa F-18 is able to cross the blood-brain barrier and is taken up by brain tumor cells. As uptake is higher in tumor cells, tumors may then be imaged using positron emission tomography (PET). Assessing tumor uptake of FDOPA may be beneficial for diagnosis, localization and in determining further treatment. The clinical usefulness of Fluorodopa F-18 has been evaluated and recognised in France and subsequently in several EU countries. Fluorodopa F-18 was registered in France in 2006. 6-fluoro-(18F)-L-3,4-dihydroxyphenylalanine (FDOPA) is a large, neutral amino acid that is transported into presynaptic neurons, where it is converted by the enzyme aromatic aminoacid decarboxylase [AAAD]) into fluorodopamine-(18F), which subsequently enters cathecholamine-storage vesicles. 6-fluoro(18F)-L-dopa crosses the blood-brain barrier; therefore, when injected into the blood stream, it reaches the dopaminergic cells in the brain and is used by the brain as a precursor for dopamine. This makes it possible to monitor intracerebral synthesis and uptake of dopamine by means of the positron-emitting 6-fluoro(18F)-L-3,4-dihydroxyphenylalanine (FDOPA), in conjunction with externally-placed devices suited for detection of annihilation photons, which progressively led to the most recent positron emission tomography (PET) units. Iasodopa, the commercial preparation of FDOPA that obtained a marketing authorisation in France in November 2006 (which is currently recognised by several other EU countries), is a solution for injection. The activity available at time of administration ranges from 0.1 GBq to 0.8 GBq per vial. The half-life of the radionuclide is 109.8 min with emission of positron radiation (Emax: 0.633 MeV) followed by photon annihilation radiations of 0.511 MeV.
Status:
US Approved Rx
(2018)
Source:
NDA208700
(2018)
Source URL:
First approved in 2018
Source:
NDA208700
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Lutetium Lu 177 dotatate binds to somatostatin receptors with highest affinity for subtype 2 receptors (SSRT2). Upon binding to somatostatin
receptor expressing cells, including malignant somatostatin receptor-positive tumors, the compound is internalized. The beta emission from Lu 177
induces cellular damage by formation of free radicals in somatostatin receptor-positive cells and in neighboring cells. LUTATHERA® (lutetium Lu 177 dotatate) is indicated for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults.
Status:
US Approved Rx
(2016)
Source:
NDA208054
(2016)
Source URL:
First approved in 2016
Source:
NDA208054
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Trans-1-amino-3-[(18)F]fluorocyclobutanecarboxylic acid (also known as Fluciclovine (18F)) was approved under brand name AXUMIN as a radioactive diagnostic agent indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence. Besides, this radioactive compound is used in patients with cervical, ovarian epithelial or endometrial cancers. Fluciclovine F 18 is a synthetic amino acid transported across mammalian cell membranes by amino acid transporters, such as LAT-1 and ASCT2, which are upregulated in prostate cancer cells, but as was shown, this compound has a higher affinity for ASCT2 in comparison with other transporters.
Status:
US Approved Rx
(2023)
Source:
ANDA214337
(2023)
Source URL:
First approved in 2015
Source:
NDA022225
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Sugammadex (ORG 25969) is a cyclodextrin derivative was synthesized as synthetic receptor (or host molecule) for neuromuscular blockers (rocuronium and vecuronium). It forms a complex with the neuromuscular blocking agents rocuronium and vecuronium, and it reduces the amount of neuromuscular blocking agent available to bind to nicotinic cholinergic receptors in the neuromuscular junction. This results in the reversal of neuromuscular blockade induced by rocuronium and vecuronium. The clinical use of sugammadex promises to eliminate many of the shortcomings in current anesthetic practice with regard to antagonism of rocuronium and other aminosteroid muscle relaxants. Sugammadex is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery.
Status:
US Approved Rx
(2014)
Source:
NDA204677
(2014)
Source URL:
First approved in 2014
Source:
NDA204677
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Florbetaben F18 is a18F-labeled stilbene derivative used as a tracer for PET imaging of beta-amyloid deposits in the human brain. The F 18 isotope produces a positron signal that is detected by a PET scanner. 3H-florbetaben in vitro binding experiments reveal two binding sites (Kd of 16 nM and 135 nM) in frontal cortex homogenates from patients with AD. Binding of florbetaben F18 to beta-amyloid plaques in post-mortem brain sections from patients with AD using autoradiography correlates with both immunohistochemical and Bielschowsky silver stains. Florbetaben F 18 does not bind to tau or alpha-synuclein in tissue from patients with AD. Neither Neuraceq nor non-radioactive florbetaben F 19 bind to AT8 positive tau deposits in brain tissue from patients with frontotemporal dementia (FTD), using autoradiography and immunohistochemistry, respectively.
Status:
US Approved Rx
(2014)
Source:
NDA203684
(2014)
Source URL:
First approved in 2014
Source:
NDA203684
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
SULFUR HEXAFLUORIDE is a component of LUMASON® (sulfur hexafluoride lipid-type A microspheres). It is an ultrasound contrast agent indicated for use in the heart echocardiography and in ultrasonography of the liver and the urinary tract. The sulfur hexafluoride lipid microspheres are composed of SF6 gas in the core surrounded by an outer shell monolayer of phospholipids with palmitic acid as a stabilizer.
Status:
US Approved Rx
(2013)
Source:
NDA203137
(2013)
Source URL:
First approved in 2013
Source:
NDA203137
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Flutemetamol F 18 is a radioactive molecular agent that is intended for use with PET imaging of the brain in adults being evaluated for Alzheimer's disease (AD) and dementia. Flutemetamol F 18 consists of flutemetamol, a thioflavin derivative of Pittsburgh compound B (PiB) labeled with the radioisotope fluorine F18 and it selectively binds to cerebral fibrillar beta-amyloid, a peptide involved in Alzheimer's disease.
Status:
US Approved Rx
(2012)
Source:
NDA202008
(2012)
Source URL:
First approved in 2012
Source:
NDA202008
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Florbetapir (18F) (trade name AMYViD; also known as florbetapir-fluorine-18 or 18F-AV-45) is a PET scanning radiopharmaceutical compound containing the radionuclide fluorine-18, recently FDA approved as a diagnostic tool for Alzheimer's disease. Florbetapir, like Pittsburgh compound B (PiB), binds to beta-amyloid, however fluorine-18 has a half-life of 110 minutes, in contrast to PiB's radioactive half life of 20 minutes. Wong et al. found that the longer life allowed the tracer to accumulate significantly more in the brains of people with AD, particularly in the regions known to be associated with beta-amyloid deposits. A negative Amyvid scan indicates sparse to no neuritic plaques, and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patient’s cognitive impairment is due to AD. A positive Amyvid scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with AD, but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition. Amyvidis an adjunct to other diagnostic evaluations