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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
(2019)
Source:
BLA208157
(2019)
Source URL:
First approved in 1982
Source:
BLA018780
Source URL:
Class:
PROTEIN
Conditions:
Human Insulin, also known as Regular Insulin, is a short-acting form of insulin used for the treatment of hyperglycemia caused by Type 1 and Type 2 Diabetes. Human insulin is produced by recombinant DNA technology and is identical to endogenously produced insulin. Insulin lowers blood glucose levels by stimulating peripheral glucose uptake by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis in adipocytes, inhibits proteolysis, and enhances protein synthesis.
Human insulin begins to exert its effects within 30 minutes of subcutaneous administration, while peak levels occur 3-4 hours after administration. Due to its quick onset of action, human insulin is considered "bolus insulin" as it provides high levels of insulin in a short period of time to mimic the release of endogenous insulin from the pancreas after meals. Bolus insulin is often combined with once daily, long-acting "basal insulin" to provide low concentrations of background insulin that can keep blood sugar stable between meals or overnight. Use of basal and bolus insulin together is intended to mimic the pancreas' production of endogenous insulin, with a goal of avoiding any periods of hypoglycemia.
Status:
US Approved Rx
(1978)
Source:
BLA101063
(1978)
Source URL:
First approved in 1978
Source:
BLA101063
Source URL:
Class:
PROTEIN
Status:
US Approved Rx
(2000)
Source:
BLA021149
(2000)
Source URL:
First approved in 1976
Source:
BLA017692
Source URL:
Class:
PROTEIN
Status:
US Approved Rx
(1976)
Source:
BLA017837
(1976)
Source URL:
First approved in 1976
Source:
BLA017837
Source URL:
Class:
PROTEIN
Status:
US Approved Rx
(1987)
Source:
BLA017881
(1987)
Source URL:
First approved in 1976
Source:
PULMOLITE by JUBILANT DRAXIMAGE
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