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Status:
US Approved Rx
(1994)
Source:
NDA020287
(1994)
Source URL:
First approved in 1994
Source:
NDA020287
Source URL:
Class:
POLYMER
Status:
US Approved Rx
(2014)
Source:
ANDA076726
(2014)
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
(2023)
Source:
ANDA216517
(2023)
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
(1974)
Source:
BLA050114
(1974)
Source URL:
First approved in 1974
Source:
BLA050114
Source URL:
Class:
POLYMER
Conditions:
Benzylpenicilloyl Polylysine is a skin-testing reagent which used to detect immunoglobulin E antibodies in people with a history of penicillin allergy. The quantitation of in vitro IgE antibodies to the benzylpenicilloyl determinant is a useful tool for evaluating allergic subjects.
A penicillin skin test predicts only the presence of IgE antibodies for the major or minor penicillin determinants at the time of application and does not predict the future development of IgE-mediated reactions during subsequent courses of penicillin. Benzylpenicilloyl polylysine reacts specifically with penicilloyl skin sensitizing antibodies (reagins) to produce immediate wheal and flare reactions which may reflect increased risk of allergic reactions to subsequent penicillin therapy. The use of benzylpenicilloyl polylysine can detect between 75-90% of all positive reactions to penicillin. Benzylpenicilloyl polylysine was FDA approved in 2009 for the assessment of sensitization to penicillin (benzylpenicillin or penicillin G) in those patients suspected of having a clinical hypersensitivity to penicillin.
Status:
US Approved Rx
(2020)
Source:
ANDA209599
(2020)
Source URL:
First approved in 1964
Class:
POLYMER
Status:
US Approved Rx
(1984)
Source:
NDA018983
(1984)
Source URL:
First approved in 1963
Source:
Topex Mint by Dentsply LLC. Professional Division Trading as Sultan Healthcare
Source URL:
Class:
POLYMER
Status:
US Approved Rx
(1998)
Source:
ANDA040029
(1998)
Source URL:
First approved in 1953
Source:
NDA022556
Source URL:
Class:
POLYMER
Status:
US Approved Rx
(2020)
Source:
ANDA212060
(2020)
Source URL:
First approved in 1939
Source:
LIQUAEMIN SODIUM by ORGANON USA INC
Source URL:
Class:
POLYMER
Нeparin (or Unfractionated heparin ) is an anticoagulant indicated for both the prevention and treatment of thrombotic events such as deep vein thrombosis (DVT) and pulmonary embolism (PE) as well as atrial fibrillation (AF). Heparin can also be used to prevent excess coagulation during procedures such as cardiac surgery, extracorporeal circulation or dialysis, including continuous renal replacement therapy. Heparin administration can be by intravenous (or subcutaneous route. Intravenous heparin is continuously administered for therapeutic anticoagulation, while intermittent subcutaneous administration is used to prevent thromboembolism. Once administered, heparin binds reversibly to antithrombin III (ATIII) and greatly accelerates the rate at which ATIII inactivates coagulation enzymes thrombin (factor IIa) and factor Xa. The heparin-ATIII complex can also inactivate factors IX, XI, XII, and plasmin, but the antithrombotic effect of heparin is well correlated to the inhibition of factor Xa. Typical adverse effects from heparin use include bleeding, thrombocytopenia, injection site reactions, and other adverse effects only seen with chronic heparin administration. Bleeding is a major complication associated with heparin use. Patients should undergo monitoring for new bleeding that may present in the urine or stool. Bleeding may also present as bruising, petechial rash and nosebleeds.
Status:
US Approved Rx
(2002)
Source:
NDA021321
(2002)
Source URL:
First marketed in 1921
Class:
POLYMER
Conditions:
Icodextrin is a colloid osmotic agent, derived from maltodextrin, used in form of an aqueous solution for peritoneal dialysis under the trade name Extraneal and after gynecological laparoscopic surgery for the reduction of post-surgical adhesions (fibrous bands that form between tissues and organs) under the trade name Adept. Icodextrin is a starch-derived, water-soluble glucose polymer linked by alpha (1-4) and less than 10% alpha (1-6) glucosidic bonds. Icodextrin. Icodextrin acts in the peritoneal cavity by exerting osmotic pressure across small intercellular pores resulting in transcapillary ultrafiltration throughout the dwell. Like other peritoneal dialysis solutions, Extraneal also contains electrolytes to help normalize electrolyte balance and lactate to help normalize acid-base status. Absorption of icodextrin from the peritoneal cavity follows zero-order kinetics consistent with convective transport via peritoneal lymphatic pathways. Icodextrin is metabolized by alpha-amylase into oligosaccharides with a lower degree of polymerization, including maltose, maltotriose, maltotetraose, and higher molecular weight species
Status:
US Approved Rx
(2022)
Source:
BLA761192
(2022)
Source URL:
First approved in 2022
Source:
BLA761192
Source URL:
Class:
STRUCTURALLY DIVERSE