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Search results for "ORPHAN DRUG|Designated/Withdrawn" in comments (approximate match)
Status:
Investigational
Source:
NCT01593072: Phase 1 Interventional Withdrawn Ebola Hemorrhagic Fever
(2012)
Source URL:
Class:
NUCLEIC ACID
Status:
Investigational
Source:
NCT02226965: Phase 2 Interventional Completed Lymphoma, Diffuse Large B-Cell
(2014)
Source URL:
Class:
NUCLEIC ACID
Status:
Investigational
Source:
NCT02974322: Phase 3 Interventional Withdrawn Crohn Disease
(2017)
Source URL:
Class:
NUCLEIC ACID
Status:
Investigational
Source:
NCT02319005: Phase 3 Interventional Completed Transthyretin (TTR) Mediated Familial Amyloidotic Cardiomyopathy (FAC)
(2014)
Source URL:
Class:
NUCLEIC ACID
Status:
Designated
Source:
FDA ORPHAN DRUG:173903
Source URL:
Class:
NUCLEIC ACID
Status:
US Approved Rx
(2020)
Source:
ANDA212060
(2020)
Source URL:
First approved in 1939
Source:
LIQUAEMIN SODIUM by ASPEN GLOBAL 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:
Investigational
Source:
NCT01764880: Phase 1 Interventional Completed Multiple Myeloma
(2012)
Source URL:
Class:
POLYMER
Status:
First approved in 1953
Class:
POLYMER
Conditions:
Tyloxapol is a nonionic liquid polymer of the alkyl aryl polyether alcohol type that is used as a surfactant to aid liquefaction and removal of mucopurulent (containing mucus and pus) bronchopulmonary secretions. Tyloxapol is also used as a detergent, dispersing agent, encapsulating agent and a hydroxy radical scavenger. Tyloxapol has been used as a mucolytic agent for over 50 years and has proven to be well tolerated during this time. Tyloxapol influences the respiratory system by the following four different action mechanisms: secretolytic action, reduction of surface tension, dissolution of coatings and down-regulation of inflammation. Several studies have shown that small quantities of Tyloxapol applied as an aerosol liquefy sputum. The viscosity of sputum is reduced by 10% to 20% according to rotational viscosimetry measurements. Tyloxapol also penetrates the mucous wall and dissolves viscous and dried secretions, thus enabling increased ciliary activity in the respiratory tract. Although the mechanism of Tyloxapol has been well described, and there is a long-standing basis for its clinical usefulness, there are almost no randomized, double-blind, placebo-controlled trials available that demonstrate the superiority of Tyloxapol vs. saline. Side-effects in the form of hypersensitivity reactions have only occurred very rarely.
Status:
US Approved Rx
(2017)
First approved in 2017
Class:
STRUCTURALLY DIVERSE
Status:
US Approved Rx
(1999)
First approved in 1998
Source:
BLA103869
Source URL:
Class:
STRUCTURALLY DIVERSE