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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 Previously Marketed
Source:
MIVACRON by ABBVIE
(1992)
Source URL:
First approved in 1992
Source:
MIVACRON by ABBVIE
Source URL:
Class:
MIXTURE
Conditions:
Mivacurium chloride (Mivacron) is a new benzylisoquinolinium choline-like diester neuromuscular blocking drug with an onset of action at equipotent doses that is comparable to atracurium and vecuronium but slower than succinylcholine. MIVACRON (a mixture of three stereoisomers) binds competitively to cholinergic receptors on the
motor end-plate to antagonize the action of acetylcholine, resulting in a block of neuromuscular
transmission. This action is antagonized by acetylcholinesterase inhibitors, such as neostigmine. MIVACRON is a short-acting neuromuscular blocking agent indicated for inpatients and outpatients,
as an adjunct to general anesthesia, to facilitate tracheal intubation and to provide skeletal muscle
relaxation during surgery or mechanical ventilation.
Status:
US Previously Marketed
Source:
NUROMAX by ABBVIE
(1991)
Source URL:
First approved in 1991
Source:
NUROMAX by ABBVIE
Source URL:
Class:
MIXTURE
Conditions:
Doxacurium chloride (formerly recognized as BW938U80 or BW A938U) is a neuromuscular-blocking drug or skeletal muscle relaxant in the category of non-depolarizing neuromuscular-blocking drugs, used adjunctively in anesthesia for endotracheal intubation or to facilitate mechanical ventilation. Unlike a number of other related skeletal muscle relaxants, it is rarely used adjunctively to facilitate endotracheal intubation. Doxacurium chloride is a mixture of three trans, trans stereoisomers, a dl pair [(1R,1'R ,2S,2'S ) and (1S,1'S ,2R,2'R )] and a meso form (1R,1'S,2S,2'R). NUROMAX binds competitively to cholinergic receptors on the motor end-plate to antagonize the action of acetylcholine, resulting in a block of neuromuscular transmission. This action is antagonized by acetylcholinesterase inhibitors, such as neostigmine.
Status:
US Previously Marketed
Source:
MOCTANIN by ETHITEK
(1985)
Source URL:
First approved in 1985
Source:
MOCTANIN by ETHITEK
Source URL:
Class:
MIXTURE
Conditions:
Glyceryl 1-caprylate (Monooctanoin, Capmul 8210), a semisynthetic esterified glycerol, a cholesterol solvent, that has been used for the dissolution of retained cholesterol gallstones following cholecystectomy. Bile duct infusion of monooctanoin is associated with little toxicity, although potentially serious problems can result from absorption of the drug or tissue infiltration. Gastrointestinal side effects such as anorexia, nausea, vomiting, diarrhea, and abdominal pain have been reported most commonly. Complete gallstone dissolution has occurred in approximately 50-75 percent of patients receiving monooctanoin. Although mechanical stone removal is still considered to be the treatment of choice for retained gallstones, monooctanoin use appeared promising for stone dissolution in patients in whom mechanical removal has been unsuccessful or is impossible. Monoctanoin was approved by the U.S. Food and Drug Administration (FDA) on Oct 29, 1985. It was developed and marketed as Moctanin® by ETHITEK in US.
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:
21 CFR 310.545(a)(22)(ii) antifungal:diaper rash basic fuchsin
Source URL:
First approved in 1972
Source:
21 CFR 333A
Source URL:
Class:
MIXTURE
Conditions:
Fuchsine (rosaniline hydrochloride) is a magenta dye. Basic fuchsine is a mixture of rosaniline, pararosaniline, new fuchsine and Magenta II. Carbol fuchsin is a mixture of phenol and basic fuchsin, used in bacterial staining procedures. It is commonly used in the staining of mycobacteria as it has an affinity for the mycolic acids found in their cell membranes. The World Health Organization recommendation of 0.3% carbol fuchsin in the ZN method for staining acid-fast bacilli (AFB).
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:
First approved in 1964
Class:
MIXTURE
Targets:
Conditions:
This bioactive compound was named candicidin, because of its high activity on Candida albicans. Candicidin is a polyene antifungal antibiotic produced by a strain of Streptomyces griseus. It is especially effective against Candida albicans (more effective than amphotericin B), and is administered intravaginally in the treatment of vulvovaginal candidiasis. Candicidin inhibits cell membrane of Candida albicans, resulting in disruption of membrane integrity and ultimately cell death. There is some evidence that the binding site in the cell wall may be to fatty acids or fatty acid esters and that this binding capacity must be satisfied before candicidin can bring about its lethal effect by binding to sterol in the cell membrane.
Status:
US Previously Marketed
First approved in 1964
Source:
VIRAC REX by CHESEBROUGH PONDS
Source URL:
Class:
MIXTURE
Conditions:
Formed as a complex of iodine with undecoylium chloride, undecoylium chloride iodine is a cationic detergent typically used as a topical antigermicidal agent.
Status:
US Previously Marketed
Source:
CALCIUM GLUCEPTATE by ABRAXIS PHARM
(1987)
Source URL:
First approved in 1961
Source:
CALCIUM GLUCEPTATE by LILLY
Source URL:
Class:
MIXTURE
Conditions:
Calcium gluceptate (also known as calcium glucoheptonate) was used, as calcium supplements by people who were unable to get enough calcium or who was needed it more. This drug was used to prevent and to treat several conditions, related to the hypocalcemia (not enough calcium in the blood). The body needs calcium to make strong bones; it is also needed for the heart, muscles, and nervous system to work properly. Nevertheless, that use of calcium gluceptate was discontinued.