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Search results for "ORPHAN DRUG|Designated/Withdrawn" in comments (approximate match)
Status:
US Approved Rx
(1990)
Source:
BLA103836
(1990)
Source URL:
First approved in 1990
Source:
BLA103836
Source URL:
Class:
PROTEIN
Status:
US Approved Rx
(1989)
Source:
BLA103234
(1989)
Source URL:
First approved in 1989
Source:
BLA103234
Source URL:
Class:
PROTEIN
Status:
US Approved Rx
(2003)
First approved in 1987
Source:
PROLASTIN-C by GRIFOLS THERAPEUTICS LLC
Source URL:
Class:
PROTEIN
Status:
US Approved Rx
(2024)
Source:
NDA218771
(2024)
Source URL:
First approved in 1987
Source:
PARATHAR by SANOFI AVENTIS US
Source URL:
Class:
PROTEIN
Conditions:
Teriparatide was manufactured under the brand name FORTEO. FORTEO contains recombinant human parathyroid hormone (1-34), [rhPTH(1-34)], which has an identical sequence to the 34 N-terminal amino acids (the biologically active region) of the 84-amino acid human parathyroid hormone, that regulates calcium and phosphate in the body. FORTEO is indicated for the treatment of postmenopausal women with severe osteoporosis who are at high risk of fracture or who have failed or are intolerant to previous osteoporosis therapy. In addition, Forteo is used for the treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in men and women who are at increased risk for fracture. The biological actions of teriparatide is mediated through binding to specific high-affinity cell-surface receptors. Teriparatide is not expected to accumulate in bone or other tissues.
Status:
US Approved Rx
(1986)
Source:
BLA103132
(1986)
Source URL:
First approved in 1986
Source:
BLA103132
Source URL:
Class:
PROTEIN
Status:
US Approved Rx
(2021)
Source:
ANDA212416
(2021)
Source URL:
First approved in 1975
Source:
CALCIMAR by SANOFI AVENTIS US
Source URL:
Class:
PROTEIN
Conditions:
Calcitonin-salmon is a polypeptide hormone secreted by the parafollicular cells of the ultimobranchial gland of salmon fish. Calcitonin-salmon Nasal Spray is a polypeptide of 32 amino acids manufactured by recombinant DNA technology and is identical to calcitonin produced by salmon fish or chemical synthesis. Calcitonin acts primarily on bone, but direct renal effects and actions on the gastrointestinal tract are also recognized. Calcitonin-salmon appears to have actions essentially identical to calcitonins of mammalian origin, but its potency per mg is greater and it has a longer duration of action. The actions of calcitonin on bone and its role in normal human bone physiology are still not completely elucidated, although calcitonin receptors have been discovered in osteoclasts and osteoblasts. Single injections of calcitonin cause a marked transient inhibition of the ongoing bone resorptive process. With prolonged use, there is a persistent, smaller decrease in the rate of bone resorption. Histologically, this is associated with a decreased number of osteoclasts and an apparent decrease in their resorptive activity. In vitro studies have shown that calcitonin-salmon causes inhibition of osteoclast function with loss of the ruffled osteoclast border responsible for resorption of bone. Calcitonin-salmon Nasal Spray is indicated for the treatment of postmenopausal osteoporosis in females greater than 5 years postmenopause with low bone mass relative to healthy premenopausal females.
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
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:
Investigational
Source:
INN:cebsulfase alfa [INN]
Source URL:
Class:
PROTEIN
Class:
PROTEIN