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Search results for "ORPHAN DRUG|Designated" in comments (approximate match)
Status:
Possibly Marketed Outside US
Source:
NCT03538327: Phase 4 Interventional Completed Hypertension
(2013)
Source URL:
First approved in 2016
Source:
21 CFR 352
Source URL:
Class:
MIXTURE
Status:
Possibly Marketed Outside US
Source:
NCT01284647: Phase 4 Interventional Completed Chronic Erosive Gastritis
(2011)
Source URL:
First approved in 2010
Source:
21 CFR 352
Source URL:
Class:
MIXTURE
Targets:
Conditions:
Tetraprenylacetone (Geranylgeranylacetone) is an anti-peptic ulcer drug developed and approved in Japan in 1984. Tetraprenylacetone is shown to suppress H. pylori induced tissue and cell injury and inflammatory reaction, so it is expected to show beneficial effects on H. pylori-infected tissues. Tetraprenylacetone is used to treat patients suffering from peptic ulcers and gastritis. In Japan it is sold under the brand name Selbex.
Status:
Possibly Marketed Outside US
First approved in 2000
Source:
21 CFR 352
Source URL:
Class:
MIXTURE
Status:
US Approved Rx
(2007)
Source:
NDA022074
(2007)
Source URL:
First approved in 2007
Source:
NDA022074
Source URL:
Class:
PROTEIN
Conditions:
Lanreotide is a medication used in the management of acromegaly and symptoms caused by neuroendocrine tumors, most notably carcinoid syndrome. It is a long-acting analog of somatostatin. It is available in several countries, including the United Kingdom, Australia and Canada, and was approved for sale in the United States by the Food and Drug Administration on August 30, 2007. Lanreotide was developed in the lab of Dr. David H. Coy, School of Medicine. Dr. Coy serves as Director of the Peptide Laboratory. Lanreotide (as lanreotide acetate) is manufactured by Ipsen, and marketed under the trade name Somatuline. The mechanism of action of lanreotide is believed to be similar to that of natural somatostatin. Lanreotide has a high affinity for human somatostatin receptors (SSTR) 2 and 5 and a reduced binding affinity for human SSTR1, 3, and 4. Activity at human SSTR 2 and 5 is the primary mechanism believed responsible for GH inhibition. Like somatostatin, lanreotide is an inhibitor of various endocrine, neuroendocrine, exocrine and paracrine functions. Lanreotide inhibits the basal secretion of motilin, gastric inhibitory peptide and pancreatic polypeptide, but has no significant effect on the secretion of secretin. Lanreotide inhibits postprandial secretion of pancreatic polypeptide, gastrin and cholecystokinin (CCK). In healthy subjects, lanreotide produces a reduction and a delay in post-prandial insulin secretion, resulting in transient, mild glucose intolerance.
Status:
US Approved Rx
(2003)
Source:
BLA103979
(2003)
Source URL:
First approved in 2003
Source:
BLA103979
Source URL:
Class:
PROTEIN
Status:
US Approved Rx
(2001)
Source:
NDA021288
(2001)
Source URL:
First approved in 2000
Source:
NDA020715
Source URL:
Class:
PROTEIN
Conditions:
Triptorelin is a synthetic decapeptide agonist analog of luteinizing hormone releasing hormone (LHRH). It works by decreasing the production of certain hormones, which reduces testosterone levels in the body. Animal studies comparing triptorelin to native GnRH found that triptorelin had 13 fold higher releasing activity for luteinizing hormone, and 21-fold higher releasing activity for follicle-stimulating hormone. Triptorelin is indicated for the palliative treatment of advanced prostate cancer.
Status:
US Approved Rx
(1996)
Source:
BLA020162
(1996)
Source URL:
First approved in 1996
Source:
BLA020162
Source URL:
Class:
PROTEIN
Conditions:
Corticorelin ovine is an analogue of the naturally occurring human corticotropin-releasing hormone (hCRH) peptide. Corticorelin ovine is a potent stimulator of adrenocorticotropic hormone (ACTH) release from the anterior pituitary. ACTH stimulates cortisol production from the adrenal cortex. Corticorelin ovine was marketed under the brand name ACTHREL for use in differentiating pituitary and ectopic production of ACTH in patients with ACTH-dependent Cushing’s syndrome.
Status:
US Approved Rx
(1982)
Source:
NDA017707
(1982)
Source URL:
First approved in 1982
Source:
NDA017707
Source URL:
Class:
PROTEIN
Conditions:
Indium In-111 pentetate disodium is a radioactive diagnostic indicated for use in radionuclide cisternography. Decay of In-111 by electron capture allows for detection with a gamma camera for visualization of the brain and spinal column. Indium In 111 pentetate ( 111In-DTPA) is indicated as an imaging agent in cisternography to study the flow of cerebrospinal fluid (CSF) in the brain, to diagnose abnormalities in CSF circulation, to assess and help localize the site of CSF leakage, and to test the patency of or localize blocks in CSF shunts.
Status:
US Approved Rx
(1996)
Source:
BLA020604
(1996)
Source URL:
First approved in 1976
Class:
PROTEIN
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