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Status:
US Approved Rx
(2001)
Source:
BLA103949
(2001)
Source URL:
First approved in 2001
Source:
BLA103949
Source URL:
Class:
PROTEIN
Status:
US Approved Rx
(2001)
Source:
BLA103950
(2001)
Source URL:
First approved in 2001
Source:
BLA103950
Source URL:
Class:
PROTEIN
Status:
US Approved Rx
(2001)
Source:
BLA103948
(2001)
Source URL:
First approved in 2001
Source:
BLA103948
Source URL:
Class:
PROTEIN
Status:
US Approved Rx
(2001)
Source:
BLA103951
(2001)
Source URL:
First approved in 2001
Source:
BLA103951
Source URL:
Class:
PROTEIN
Status:
US Previously Marketed
Source:
NATRECOR by SCIOS LLC
(2001)
Source URL:
First approved in 2001
Source:
NDA020920
Source URL:
Class:
PROTEIN
Conditions:
Nesiritide is the recombinant form of the 32 amino acid human B-type natriuretic peptide (BNP), which is normally produced by the ventricular myocardium. Human BNP binds to the particulate guanylate cyclase receptor of vascular smooth muscle and endothelial cells, leading to increased intracellular concentrations of guanosine 3'5'-cyclic monophosphate (cGMP) and smooth muscle cell relaxation. Cyclic GMP serves as a second messenger to dilate veins and arteries. Nesiritid was sold under brand name Natrecor for the intravenous treatment of patients with acutely decompensated congestive heart failure who have dyspnea at rest or with minimal activity.
Status:
US Previously Marketed
Source:
Xigris
(2001)
Source URL:
First approved in 2001
Source:
Xigris
Source URL:
Class:
PROTEIN
Status:
Possibly Marketed Outside US
Source:
21 CFR 352
(2016)
Source URL:
First approved in 2001
Source:
M020
Source URL:
Class:
POLYMER
Status:
Possibly Marketed Outside US
Source:
M020
(2001)
Source URL:
First approved in 2001
Source:
M020
Source URL:
Class:
POLYMER
Status:
Possibly Marketed Outside US
Source:
21 CFR 333D
(2007)
Source URL:
First approved in 2001
Source:
21 CFR 352
Source URL:
Class:
POLYMER
Status:
Possibly Marketed Outside US
Source:
21 CFR 333C
(2013)
Source URL:
First approved in 2001
Source:
M017
Source URL:
Class:
POLYMER
