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Search results for "Established Pharmacologic Class [EPC]" in comments (approximate match)
Status:
US Approved Allergenic Extract
(1941)
Source:
BLA103888
(1941)
Source URL:
First approved in 1941
Source:
BLA103888
Source URL:
Class:
MIXTURE
Status:
US Approved Allergenic Extract
(1974)
Source:
BLA102223
(1974)
Source URL:
First approved in 1941
Source:
BLA103888
Source URL:
Class:
MIXTURE
Status:
US Approved Allergenic Extract
(1994)
Source:
BLA103738
(1994)
Source URL:
First marketed in 1921
Class:
MIXTURE
Targets:
Conditions:
Rosin is a natural product derived from pine trees and consists of a complex mixture of mutually soluble organic compounds. Rosin (colophony) is composed of approximately 70% resin acids. Rosins are produced commercially by one of the following three methods: (1) solvent extraction of aged and ground pine stumps (wood rosin), (2) extraction of crude tall oil as a byproduct of the Kraft pulping process for making paper followed by acidification and fractional distillation (tall oil rosin) and, (3) tapping the living tree to collect oleoresin followed by distillation to yield turpentine and a resinous substance (gum rosin). Because, gum, tall oil and wood rosins are obtained from pine trees, they are similar in composition. Rosin and its derivatives also exhibit wide ranging pharmaceutical applications. Rosin derivatives show excellent film forming and coating properties. They are also used for tablet film and enteric coating purpose. Rosins have also been used to formulate microcapsules and nanoparticles. Glycerol, sorbitol, and mannitol esters of rosin are used as chewing gum bases for medicinal applications. The degradation and biocompatibility of rosin and rosin-based biomaterials has been examined in vitro and in vivo. Rosin Gum is an important raw material for the manufacture of soap, paper, paint, and rubber; intermediate material for synthetic organic chemicals. Rosin in Rhodiola rosea L. preparations can effect the central nervous system by increasing the ability to concentrate, the mental and physical power; they are efficient in the asthenic states and improve general resistance of the cells and the organism against the harmful outer influence. They also prevent the heart system from stress and arrhythmias, and posses some antioxidant activity. Some data confirm that the Rhodiola rosea L. preparations stop the growth of the malignant tumors and metastases in the liver.
Status:
US Approved Allergenic Extract
Source:
BLA103888
Source URL:
Class:
MIXTURE
Status:
US Previously Marketed
Source:
EPANOVA by ASTRAZENECA
(2014)
Source URL:
First approved in 2014
Source:
EPANOVA by ASTRAZENECA
Source URL:
Class:
MIXTURE
Status:
US Previously Marketed
First approved in 2012
Class:
MIXTURE
Status:
US Previously Marketed
Source:
SECRETIN-FERRING by FERRING
(1981)
Source URL:
First approved in 1981
Source:
SECRETIN-FERRING by FERRING
Source URL:
Class:
MIXTURE
Secretin is a peptide hormone produced by S-cells of the small intestinal mucosa and involved in the regulation of pancreatic secretory activity. S-cells that are located in the mucous membrane of the duodenum and in the proximal part of the jejunum secrete the polypeptide prosecretin, an inactive precursor of secretin, which turns into secretin by the action of hydrochloric acid of the gastric juice. Being absorbed into the blood, secretin reaches the pancreas and pancreatic centroacinar cells have secretin receptors in their plasma membrane. As secretin binds to these receptors, it enhances the secretion of bicarbonate-rich fluid that flows into the intestine. Bicarbonate is a base that neutralizes the acid, thus establishing a pH favorable to the action of other digestive enzymes in the small intestine. Secretin also increases water and bicarbonate secretion from duodenal Brunner's glands to buffer the incoming protons of the acidic chyme and also reduces acid secretion by parietal cells of the stomach. Secretin is used in a diagnostic test for pancreatic function.
Status:
US Previously Marketed
Source:
LACRISERT by BAUSCH AND LOMB INC
(1981)
Source URL:
First approved in 1975
Source:
NDA017579
Source URL:
Class:
MIXTURE
Status:
US Previously Marketed
Source:
CAPASTAT SULFATE by EPIC PHARMA LLC
(1971)
Source URL:
First approved in 1971
Source:
CAPASTAT SULFATE by EPIC PHARMA LLC
Source URL:
Class:
MIXTURE
Targets:
Conditions:
Capreomycin is an antibiotic, which is used in combination other antituberculosis drugs fro the treatment of pulmonary infections caused by capreomycin-susceptible strains of M. tuberculosis when the primary agents (isoniazid, rifampin, ethambutol, aminosalicylic acid, and streptomycin) have been ineffective or cannot be used because of toxicity or the presence of resistant tubercle bacilli. Little is known about capreomycin's exact mechanism of action, but it is thought to inhibit protein synthesis by binding to the 70S ribosomal unit. Capreomycin also binds to components in the bacterial cell which result in the production of abnormal proteins.
Status:
US Previously Marketed
Source:
ERGOLOID MESYLATES by SUN PHARM INDUSTRIES
(1981)
Source URL:
First approved in 1953
Class:
MIXTURE
Targets:
Ergoloid mesylates (USAN), co-dergocrine mesilate (BAN) or dihydroergotoxine mesylate, trade name Hydergine, is a mixture of the methanesulfonate salts of three dihydrogenated ergot alkaloids (dihydroergocristine, dihydroergocornine, and alpha- and beta-dihydroergocryptine). It was developed by Albert Hofmann (the inventor of LSD) for Sandoz (now part of Novartis). Ergoloid mesylates act centrally, decreasing vascular tone and slowing the heart rate, and acts peripherally to block alpha-receptors. One other possible mechanism is the effect of ergoloid mesylates on neuronal cell metabolism, resulting in improved oxygen uptake and cerebral metabolism, thereby normalizing depressed neurotransmitter levels. Ergoloid Mesylate may increase cerebral metabolism and blood flow. The role of this medication in the therapy of dementia is controversial. A recent controlled study in patients with Alzheimer's disease found that there was no advantage to the use of ergoloid mesylates compared to placebo, suggesting that ergoloid mesylates may lower scores on some cognitive and behavioral rating scales. Further study is needed to determine the risk-benefit profile of ergoloid mesylates in the treatment of dementia.