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Status:
US Approved Rx
(1990)
Source:
BLA103836
(1990)
Source URL:
First approved in 1990
Source:
BLA103836
Source URL:
Class:
PROTEIN
Status:
US Approved Rx
(2018)
Source:
BLA125545
(2018)
Source URL:
First approved in 1989
Source:
BLA103234
Source URL:
Class:
PROTEIN
Status:
US Approved Rx
(2009)
Source:
BLA125274
(2009)
Source URL:
First approved in 1989
Source:
BLA103000
Source URL:
Class:
PROTEIN
Status:
US Approved Rx
(2023)
Source:
ANDA211097
(2023)
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