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Search results for "PART 862 -- CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES" in comments (approximate match)
Status:
Possibly Marketed Outside US
Class (Stereo):
CHEMICAL (RACEMIC)
Histidine racemate is a mixture of naturally occurring essential amino acid L-histidine and its enantiomer D-histidine. D-histidine is less readily utilized than the natural isomer. It is not metabolized by histidase and is not readily oxidized by D-amino acid oxidase. Some fungi incorporate D-histidine into proteins as a measure of protection against hydrolases and to enhance antimicrobial activity.
Status:
US Approved Rx
(2001)
Source:
NDA021265
(2001)
Source URL:
First approved in 1947
Source:
BEROCCA PN by ROCHE
Source URL:
Class:
MIXTURE
Targets:
Conditions:
Retonol, also known as Vitamin A1, is a vitamin found in food and used as a dietary supplement. It is used to treat and prevent vitamin A deficiency. It is also used to prevent further issues in those who have measles. Retinol is used as a metabolic precursor of retinoic acid to treat skin-related conditions, such as cellulite, skin aging, photodamage.
Status:
Investigational
Source:
NCT03746769: Phase 1/Phase 2 Interventional Recruiting Diabetes Mellitus, Type 1
(2019)
Source URL:
Class:
MIXTURE
Status:
First approved in 1951
Class:
MIXTURE
Status:
Possibly Marketed Outside US
Source:
NCT03237182: Phase 4 Interventional Terminated Tuberculosis, Multidrug-Resistant
(2017)
Source URL:
First approved in 2022
Source:
Kanamycin Sulfates by KDG Impresa LLC, Aqion
Source URL:
Class:
MIXTURE
Targets:
Kanamycin (a mixture of kanamycin A, B and C) is an aminoglycoside bacteriocidal antibiotic, available in oral, intravenous, and intramuscular forms, and used to treat a wide variety of infections. It is effective against Gram-negative bacteria and certain Gram-positive bacteria. Aminoglycosides work by binding to the bacterial 30S ribosomal subunit, causing misreading of t-RNA, leaving the bacterium unable to synthesize proteins vital to its growth. Serious side effects include tinnitus or loss of hearing, toxicity to kidneys, and allergic reactions to the drug. Mixing of an aminoglycoside with beta-lactam-type antibiotics (penicillins or cephalosporins) may result in a significant mutual inactivation. Even when an aminoglycoside and a penicillin-type drug are administered separately by different routes, a reduction in aminoglycoside serum half-life or serum levels has been reported in patients with impaired renal function and in some patients with normal renal function.
Status:
Possibly Marketed Outside US
Source:
NCT03935984: Phase 4 Interventional Recruiting Primary Hyperparathyroidism
(2019)
Source URL:
Class:
MIXTURE
Status:
US Approved Rx
(2015)
Source:
BLA125511
(2015)
Source URL:
First approved in 2015
Source:
BLA125511
Source URL:
Class:
PROTEIN
Parathyroid hormone (PTH) is an 84-amino acid peptide that regulates the function of osteoblasts and osteocytes and is secreted by the parathyroid gland in response to changes in the concentration of extracellular calcium. Parathyroid hormone is approved under the brand name NATPARA as an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism. It is also available for treatment of postmenopausal osteoporosis in many European countries. Parathyroid hormone is an activator of parathyroid hormone 2 receptor. In addition, was shown, that downregulation of Notch in osteoblasts and osteocytes may represent a mechanism contributing to the anabolic effects of parathyroid hormone in bone.
Status:
US Approved Rx
(2010)
Source:
NDA022432
(2010)
Source URL:
First approved in 1950
Source:
ACTHAR by SANOFI AVENTIS US
Source URL:
Class:
PROTEIN
Conditions:
Corticotropin is a polypeptide hormone produced and secreted by the pituitary gland. Corticotropin acts through the stimulation of cell surface the adrenocorticotropic hormone (ACTH) receptors, which are primarily located on the adrenocortical cells. Corticotropin stimulates the cortex of the adrenal gland and boosts the synthesis of corticosteroids, mainly glucocorticoids but also sex steroids (androgens).
Corticotropin is indicated as monotherapy for the treatment of exacerbations of multiple sclerosis in adults and infantile spasms in infants and children under 2 years of age. Controlled clinical trials have shown Corticotropin to be effective in speeding the resolution of acute exacerbations of multiple sclerosis. However, there is no evidence that it affects the ultimate outcome or natural history of the disease. The mechanism of action of Corticotropin in the treatment of infantile spasms is unknown.
Status:
US Approved Rx
(1973)
Source:
BLA017067
(1973)
Source URL:
First approved in 1940
Class:
PROTEIN
Status:
Investigational
Source:
NCT00181623: Phase 2 Interventional Completed Lactation
(2005)
Source URL:
Class:
PROTEIN