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Search results for "Industrial Aid[C45678]|Reagent[C802]|Diagnostic Reagent" in comments (approximate match)
Status:
US Approved Rx
(1970)
Source:
NDA016750
(1970)
Source URL:
First approved in 1970
Source:
NDA016750
Source URL:
Class:
PROTEIN
Conditions:
Cosyntropin (ACTH (1–24)) is a synthetic peptide that is identical to the 24-amino acid segment at the N-terminal of adrenocorticotropic hormone. It is intended for use as a diagnostic agent in the screening of patients presumed to have adrenocortical insufficiency. Cosyntropin may bind to sites located on the adrenergic nerve endings associated with the cardiac tissue, and such binding would interfere with the neuronal reuptake of the catecholamines
Class:
PROTEIN
Status:
Possibly Marketed Outside US
Class:
PROTEIN
Status:
US Approved Rx
(1974)
Source:
BLA050114
(1974)
Source URL:
First approved in 1974
Source:
BLA050114
Source URL:
Class:
POLYMER
Conditions:
Benzylpenicilloyl Polylysine is a skin-testing reagent which used to detect immunoglobulin E antibodies in people with a history of penicillin allergy. The quantitation of in vitro IgE antibodies to the benzylpenicilloyl determinant is a useful tool for evaluating allergic subjects.
A penicillin skin test predicts only the presence of IgE antibodies for the major or minor penicillin determinants at the time of application and does not predict the future development of IgE-mediated reactions during subsequent courses of penicillin. Benzylpenicilloyl polylysine reacts specifically with penicilloyl skin sensitizing antibodies (reagins) to produce immediate wheal and flare reactions which may reflect increased risk of allergic reactions to subsequent penicillin therapy. The use of benzylpenicilloyl polylysine can detect between 75-90% of all positive reactions to penicillin. Benzylpenicilloyl polylysine was FDA approved in 2009 for the assessment of sensitization to penicillin (benzylpenicillin or penicillin G) in those patients suspected of having a clinical hypersensitivity to penicillin.
Status:
Possibly Marketed Outside US
Source:
ANADA200587
(2016)
Source URL:
First approved in 2016
Source:
ANADA200587
Source URL:
Class:
POLYMER
Gleptoferron is a macromolecular complex of beta-ferric oxyhydroxide and dextran glucoheptonic acid that has been used for iron-deficiency anemia in veterinary medicine.
Status:
US Approved Rx
(2010)
Source:
NDA022555
(2010)
Source URL:
First approved in 2010
Source:
NDA022555
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Hexaminolevulinate is an optical imaging drug. In solution form, it is instilled intravesically for use with photodynamic blue light cystoscopy as an adjunct to white light cystoscopy. After bladder instillation, hexaminolevulinate enters the bladder mucosa and is proposed to enter the intracellular space of mucosal cells where it is used as a precursor in the formation of the photoactive intermediate protoporphyrin IX (PpIX) and other photoactive porphyrins (PAPs). PpIX and PAPs are reported to accumulate preferentially in neoplastic cells as compared to normal urothelium, partly due to altered enzymatic activity in the neoplastic cells. In 2010, FDA granted approval for hexaminolevulinate hydrochloride as an optical imaging agent for cystoscopic detection of non-muscle invasive papillary cancer of the bladder for patients suspected or known to have lesion(s) on the basis of a prior cystoscopy.
Status:
US Approved Rx
(1986)
Source:
NDA019193
(1986)
Source URL:
First approved in 1986
Source:
NDA019193
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Conditions:
Methacholine (trade name Provocholine) is a synthetic choline ester that acts as a muscarinic receptor agonist. Methacholine is primarily used to diagnose bronchial hyperreactivity, which is the hallmark of asthma and also occurs in chronic obstructive pulmonary disease. This is accomplished through the bronchial challenge test, or methacholine challenge, in which a subject inhales aerosolized methacholine, leading to bronchoconstriction.
Status:
US Approved Rx
(2015)
Source:
ANDA204517
(2015)
Source URL:
First approved in 1972
Source:
FLUORINE F-18 by GE HEALTHCARE
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
FLUORIDE ION F-18 (as sodium fluoride F-18) is a radioactive diagnostic agent for positron emission tomography (PET) indicated for imaging of bone to define areas of altered osteogenic activity. FLUORIDE ION F-18 normally accumulates in the skeleton in an even fashion, with greater deposition in the axial skeleton (e.g. vertebrae and pelvis) than in the appendicular skeleton and greater deposition in the bones around joints than in the shafts of long bones. Increased FLUORIDE ION F-18 deposition in the bone can occur in areas of increased osteogenic activity during growth, infection, malignancy (primary or metastatic) following trauma, or inflammation of the bone.
Status:
US Approved Rx
(1985)
Source:
NDA020145
(1985)
Source URL:
First marketed in 1921
Source:
Spirit of Glyceryl Trinitrate U.S.P.
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Pentaerythritol tetranitrate is an organic nitrate that has been used for the treatment of angina pectoris. Upon administration, the drug undergoes exstensive metabolism to NO which causes vasodilation and the relaxation of smooth muscle cells. The compound belongs to a familiy of explosive substances and may be used accordingly.
Status:
US Approved Rx
(1985)
Source:
NDA020145
(1985)
Source URL:
First marketed in 1921
Source:
Spirit of Glyceryl Trinitrate U.S.P.
Source URL:
Class (Stereo):
CHEMICAL (OCTAHEDRAL 22)
Targets:
Conditions:
Pentaerythritol tetranitrate is an organic nitrate that has been used for the treatment of angina pectoris. Upon administration, the drug undergoes exstensive metabolism to NO which causes vasodilation and the relaxation of smooth muscle cells. The compound belongs to a familiy of explosive substances and may be used accordingly.