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Status:
US Approved Rx
(2004)
Source:
NDA021060
(2004)
Source URL:
First approved in 2004
Source:
NDA021060
Source URL:
Class:
PROTEIN
Conditions:
Ziconotide (PRIALT; SNX-111) is a neuroactive peptide, which was approved by FDA in 2004 for the management of severe chronic pain in adult patients for whom intrathecal therapy is warranted, and who are intolerant of or refractory to other treatment, such as systemic analgesics, adjunctive therapies, or intrathecal morphine. Ziconotide acts as a selective N-type voltage-gated calcium channel blocker, which leads to a blockade of excitatory neurotransmitter release from the primary afferent nerve terminals.
Status:
US Approved Rx
(2004)
Source:
BLA125084
(2004)
Source URL:
First approved in 2004
Source:
BLA125084
Source URL:
Class:
PROTEIN
Status:
US Previously Marketed
Source:
VITRASE
(2004)
Source URL:
First approved in 2004
Source:
VITRASE
Source URL:
Class:
PROTEIN
Status:
US Previously Marketed
Source:
MACUGEN by BAUSCH AND LOMB INC
(2004)
Source URL:
First approved in 2004
Source:
MACUGEN by BAUSCH AND LOMB INC
Source URL:
Class:
NUCLEIC ACID
Conditions:
Pegaptanib is a selective vascular endothelial growth factor (VEGF) antagonist indicated for the treatment of neovascular (wet) age-related macular degeneration. Pegaptanib is an aptamer, a pegylated modified single-stranded oligonucleotide, which adopts a threedimensional conformation that enables it to bind to extracellular VEGF. Pegaptanib specifically binds to the 165 isoform of VEGF, a protein that plays a critical role in angiogenesis (the formation of new blood vessels) and increased permeability (leakage from blood vessels), two of the primary pathological processes responsible for the vision loss associated with neovascular age-related macular degeneration. Pegaptanib is administered in a 0.3 mg dose once every six weeks by intravitreal injection. An intravitreal injection is one that is administered directly into the eye, more specifically, into the vitreous humour, or the jelly-like fluid within the eye.
Status:
Possibly Marketed Outside US
Source:
21 CFR 333A
(2020)
Source URL:
First approved in 2004
Source:
M020
Source URL:
Class:
POLYMER
Status:
Possibly Marketed Outside US
Source:
M006
(2004)
Source URL:
First approved in 2004
Source:
M006
Source URL:
Class:
POLYMER
Status:
Possibly Marketed Outside US
Source:
21 CFR 352
(2004)
Source URL:
First approved in 2004
Source:
21 CFR 352
Source URL:
Class:
POLYMER
Status:
Possibly Marketed Outside US
Source:
21 CFR 333A
(2020)
Source URL:
First approved in 2004
Source:
21 CFR 352
Source URL:
Class:
POLYMER
Status:
Possibly Marketed Outside US
Source:
21 CFR 333D
(2004)
Source URL:
First approved in 2004
Source:
21 CFR 333D
Source URL:
Class:
POLYMER
Status:
Possibly Marketed Outside US
Source:
21 CFR 333E
(2004)
Source URL:
First approved in 2004
Source:
21 CFR 333E
Source URL:
Class:
POLYMER