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Search results for "Established Pharmacologic Class [EPC]" in comments (approximate match)
Status:
US Approved Rx
(2000)
First approved in 1994
Source:
BLA103936
Source URL:
Class:
POLYMER
Status:
US Approved Rx
(1994)
Source:
NDA020287
(1994)
Source URL:
First approved in 1994
Source:
NDA020287
Source URL:
Class:
POLYMER
Status:
US Approved Rx
(2019)
Source:
ANDA208600
(2019)
Source URL:
First approved in 1993
Source:
NDA020164
Source URL:
Class:
POLYMER
Enoxaparin is a low molecular weight heparin used as anticoagulant medication to treat and prevent deep vein thrombosis (DVT) and pulmonary embolism (PE) including during pregnancy and following certain types of surgery. Enoxaparin is a depolymerized derivative of Unfractionated heparin produced by controlled depolymerization using alkaline hydrolysis of the heparin benzylic ester. Like Unfractionated heparin, its major anticoagulant effect is mediated by interaction with antithrombin III, which in turn inactivates serine proteases like factors IIa (thrombin), IXa and Xa. Therefore, enoxaparin indirectly inhibits the conversion of prothrombin to thrombin and reduces the thrombin-mediated conversion of fibrinogen to fibrin, thus preventing clot formation. Among parenteral anticoagulants, enoxaparin stands out for certain major advantages: rapid onset of action, higher bioavailability, once- or twice-daily dosing that can be administered by patients at home without any need for monitoring, and no reported association with catheter thrombosis. Enoxaparin has been shown to be a safe and effective drug in a wide variety of thromboembolic conditions, and two decades of available data have undoubtedly inspired significant confidence. Although these properties make it a preferred option in a wide range of clinical disorders, lack of reliable antidote and accumulation in renal dysfunction are major concerns associated with its use, which are shared, apart from Unfractionated heparin, by most other available anticoagulants.
Status:
US Approved Rx
(1977)
First approved in 1977
Class:
POLYMER
Status:
US Approved Rx
(1977)
First approved in 1977
Class:
POLYMER
Status:
US Approved Rx
(1977)
First approved in 1977
Class:
POLYMER
Status:
US Approved Rx
(2024)
Source:
ANDA217667
(2024)
Source URL:
First approved in 1977
Class:
POLYMER
Tetraethylenepentamine (TEPA) is a low-molecular-weight linear polyamine exerting metal-chelating properties. TEPA is widely used in industrial applications. The principal hazards that arise in working with TEPA are those associated with similar organic amines; namely, a corrosive action on skin and eyes. TEPA biological activity was attributed to its effect on cellular Cu levels as (a) treatment with TEPA resulted in reduction of cellular Cu, and (b) excess of Cu reversed TEPA's activity and accelerated differentiation. TEPA was shown to attenuate the differentiation of ex vivo cultured hematopoietic cells resulting in preferential expansion of early progenitors. A phase I/II trial was performed to test the feasibility and safety of transplantation of CD133+ cord blood (CB) hematopoietic progenitors cultured in media containing stem cell factor, FLT-3 ligand, interleukin-6, thrombopoietin and TEPA. Transplanting a population of CD133+ CB cells which were expanded ex vivo for 21 days using SCF, FLT3, IL-6, TPO and the copper chelator TEPA (StemEx) was feasible. The expanded cells were well tolerated, with no infusion-related adverse events observed.
Status:
US Approved Rx
(1977)
First approved in 1977
Class:
POLYMER
Status:
US Approved Rx
(1977)
First approved in 1977
Class:
POLYMER
Status:
US Approved Rx
(1977)
First approved in 1977
Class:
POLYMER