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Search results for "EU ORPHAN DRUG|Positive" in comments (approximate match)
Status:
US Approved Rx
(2005)
Source:
NDA021773
(2005)
Source URL:
First approved in 2005
Source:
NDA021773
Source URL:
Class:
PROTEIN
Conditions:
Exenatide (exendin-4) is sold under the brand name BYETTA to improve glycemic control in people with type 2 diabetes mellitus. Exenatide is a glucagon-like peptide 1 (GLP-1) receptor agonist that enhances glucose-dependent insulin secretion by the pancreatic beta cell, suppresses inappropriately elevated glucagon secretion, and slows gastric emptying. The drug also moderates peak serum glucagon levels during hyperglycemic periods following meals but does not interfere with glucagon release in response to hypoglycemia.
Status:
US Approved Rx
(2022)
Source:
BLA761268
(2022)
Source URL:
First approved in 2004
Source:
BLA125085
Source URL:
Class:
PROTEIN
Status:
US Approved Rx
(2017)
Source:
BLA761060
(2017)
Source URL:
First approved in 2000
Source:
Mylotarg
Source URL:
Class:
PROTEIN
Status:
US Approved Rx
(2024)
Source:
BLA761312
(2024)
Source URL:
First approved in 1999
Source:
BLA103767
Source URL:
Class:
PROTEIN
Status:
US Approved Rx
(1998)
Source:
BLA020772
(1998)
Source URL:
First approved in 1998
Source:
BLA020772
Source URL:
Class:
PROTEIN
Status:
US Approved Rx
(2020)
Source:
BLA761140
(2020)
Source URL:
First approved in 1997
Source:
BLA103705
Source URL:
Class:
PROTEIN
Status:
US Approved Rx
(1994)
Source:
BLA103411
(1994)
Source URL:
First approved in 1994
Source:
BLA103411
Source URL:
Class:
PROTEIN
Status:
US Approved Rx
(2018)
Source:
BLA761080
(2018)
Source URL:
First approved in 1991
Source:
BLA103353
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.