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Search results for "PART 310 -- NEW DRUGS|Subpart E--Requirements for Specific New Drugs or Devices" in comments (approximate match)
Status:
US Approved Rx
(2015)
Source:
ANDA078830
(2015)
Source URL:
First marketed in 1899
Class (Stereo):
CHEMICAL (ABSOLUTE)
The alkaloid L-(-)-scopolamine [L-(-)-hyoscine], a belladonna alkaloid, competitively inhibits muscarinic receptors for acetylcholine and acts as a nonselective muscarinic antagonist, producing both peripheral antimuscarinic properties and central sedative, antiemetic, and amnestic effects. Scopolamine acts: i) as a competitive inhibitor at postganglionic muscarinic receptor sites of the parasympathetic nervous system, and ii) on smooth muscles that respond to acetylcholine but lack cholinergic innervation. It has been suggested that scopolamine acts in the central nervous system (CNS) by blocking cholinergic transmission from the vestibular nuclei to higher centers in the CNS and from the reticular formation to the vomiting center. Scopolamine can inhibit the secretion of saliva and sweat, decrease gastrointestinal secretions and motility, cause drowsiness, dilate the pupils, increase heart rate, and depress motor function. Scopolamine is used for premedication in anesthesia and for the prevention of nausea and vomiting (post operative and associated with motion sickness).
Status:
US Approved OTC
Source:
21 CFR 347.10(a) skin protectant allantoin
Source URL:
First approved in 1961
Source:
ALLANTOMIDE ALLANTOIN by NATIONAL DRUG
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Targets:
The aluminum salt of Allantoin, Alcloxa combines the astringent and anti-microbial properties of aluminum with the anti-irritant, soothing and healing properties of Allantoin. Alcloxa is particularly suited for use in anti-perspirants, acne treatments and foot care products. Alcloxa is a compound that combine the properties of aluminum salts with the properties of allantion. The allantion component ehhances the action of the aluminum salts and serves to overcome irritations experienced by many individuals who may be sensitive to the use of aluminum alts. The aluminum component reduces sweat by causing the sweat gland ducts swell. Alcloxa also add to the antiperspirant properties the deodorant effect because of its bacteriostatic action. It showed bacteriostatic properties at concentrations of 0.2% particularly against Gram bectaria (B. subtilis, S. aureus, P. vulgaris, Pityrosporum ovale). This is ascribable to two different mechanisms: first bacterial growth is retarded due to a decrease in the amount of water present, second aluminum salt have itself an antimicrobial action. In baby products is indicated for its healing reparative action, in the treatment of diaper rash. Also is approved in haemorrhoidal product for its soothing and keratolytic action. In oral care products Alcloxa is useful for its astringent antibacterial properties. It is very indicated in formulations for sensitive teeth, periodontal and gum diseases (like gingivitis, irritable and bleeding gums). Use levels: 0.1-1%. − In antiacne products the slightly astringent effect promotes healing of pustules and acne lesions. It reduces the extension of infected skin eruptions, healing them and developing a soothing action. May be used alone or also in combinations with other antimicrobial agents in order to fight acne more effectively. Use levels: 0.5-2.0%.
Status:
US Approved OTC
Source:
21 CFR 346.10(c) anorectal:local anesthetic dibucaine
Source URL:
First marketed in 1930
Source:
Dibucaine; Nupercaine by Society of Chemical Industry in Basle, Basle, Switzerland (Ciba Company, Inc., New York, distributor).
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Dibucaine is used as a local anesthetic for surface anesthesia. It is one of the most potent and toxic of the long-acting local anesthetics and its parenteral use is restricted to spinal anesthesia. Dibucaine is used to temporarily relieve pain and itching due to: hemorrhoids or other anorectal disorders, sunburn, minor burns, minor cuts; scrapes, insect bites, minor skin irritation. This drug acts via blocking of nerve impulses by decreasing the neuronal membrane's permeability to sodium ions through sodium channel blocking. This reversibly stabilizes the membrane and inhibits depolarization, resulting in the failure of a propagated action potential and subsequent conduction blockade.
Status:
US Approved OTC
Source:
21 CFR 344.1 otic:earwax removal aid carbamide peroxide 6.5% (in anhydrous glycerin)
Source URL:
First marketed in 1921
Class (Stereo):
CHEMICAL (ACHIRAL)
Hydrogen peroxide has been used in medicine for more than 100 years. It is known in surgery as a highly useful irrigation solution by virtue of both its hemostatic and its antimicrobial effects. Hydrogen peroxide is a mild antiseptic used on the skin to prevent infection of minor cuts, scrapes, and burns. It may also be used as a mouth rinse to help remove mucus or to relieve minor mouth irritation (e.g., due to canker/cold sores, gingivitis). This product works by releasing oxygen when it is applied to the affected area. The release of oxygen causes foaming, which helps to remove dead skin and clean the area. Hydrogen peroxide is a strong oxidizing agent used in aqueous solution as a ripening agent, bleach, and topical anti-infective. It is relatively unstable and solutions deteriorate over time unless stabilized by the addition of acetanilide or similar organic materials.
Status:
US Approved OTC
Source:
21 CFR 358.710(a)(7) dandruff:dandruff sulfur
Source URL:
First marketed in 1921
Source:
Yellow Mercurous Iodide U.S.P.
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Mercury(I) iodide is a chemical compound that has been used as a drug in the 19th century, sometimes under the contemporary name of 'protiodide of mercury'. Mercury(I) iodide was used to treat a wide range of conditions; everything from acne to kidney disease and in particular was the treatment of choice for syphilis. It was available over the counter at any drugstore in the world, the most common form being a concoction of protiodide, licorice, glycerin, and marshmallow. Taken orally, and in low doses, protiodide causes excessive salivation, fetid breath, spongy and bleeding gums, and sore teeth. Excessive use or an overdose causes physical weakness, loss of teeth, hemolysing (destruction of the red blood cells) of the blood and necrosis of the bones and tissues of the body. Early signs of an overdose or excessive use are muscular tremors, chorea, and locomotor ataxia. Violent bloody vomiting and voiding also occur.
Status:
US Approved OTC
Source:
21 CFR 331.11(f) antacid glycine (aminoacetic acid)
Source URL:
First marketed in 1921
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Glycine (Cly) is a natural amino acid neurotransmitter that acts as a co-agonist at Glutamate [NMDA] receptors in the brain and is an activator of glycine receptors, GLRA1-3, GLRB. The abnormal Gly levels have been implicated in neuropsychiatric disorders. Alterations in Gly levels are implicated in several diseases of the central nervous system. Glycine was studied in phase II of clinical trials in patients with schizophrenia. The results have shown that using of glycine was associated with reduced symptoms with promising effect sizes and a possibility of improvement in cognitive function. Besides, glycine was also studied in clinical trials phase II in children with cystic fibrosis. The clinical, spirometric and inflammatory status of subjects with cystic fibrosis improved after just 8 weeks of glycine intake, suggesting that this amino acid might constitute a novel therapeutic tool for these patients. In addition, Gly was proposed as a biomarker for brain tumor malignancy. Glycine is a component of a nutrients mixture for peripheral administration to well-nourished mildly catabolic adult patients who require only short-term parenteral nutrition.
Status:
US Approved OTC
Source:
21 CFR 346.10(a) anorectal:local anesthetic benzocaine
Source URL:
First marketed in 1895
Class (Stereo):
CHEMICAL (ACHIRAL)
Benzocaine is a local anesthetic. It acts by blocking voltage-gated sodium ion channels in nerve endings. Benzocaine is available over-the counter for local anesthesia of oral and pharyngeal mucous membranes (sore throat, cold sores, mouth ulcers, toothache, sore gums, denture irritation), otic pain, and as a local anesthetic for surgical or diagnostic procedures. As a spray, benzocaine is used for temporary relief of pain and itching associated with minor burns, sunburn, minor cuts or scrapes, insect bites, or minor skin irritations. Topical application of benzocaine to gums or mouth may cause rare, but serious and potentially fatal adverse effect methemoglobinemia.
Status:
US Approved Allergenic Extract
(1941)
Source:
BLA103888
(1941)
Source URL:
First marketed in 1921
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
There is not much information about ammonium phenolate. It is known, that this a salt of phenol and it is toxic if swallowed and is toxic in contact with skin.
Status:
US Previously Marketed
Source:
21 CFR 310.536(a) nailbiting or thumbsucking deterrent sucrose octaacetate
Source URL:
First approved in 2015
Source:
Benzalkonium Chloride, Benzyl Alcohol by Meridian Animal Health
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Sucrose octaacetate is an acetylated derivative of sucrose. It can be used as a bitter additive, a denaturant for alcohol, a soaker for paper, as well as an insecticide, plasticizer for cellulosic&synthetic resin. It also can be used as an additive for paint and children's toys, etc. It can prevent mice or children from biting or tasting the goods because of its extreme bitter taste. Sucrose octaacetate was determined by the EPA to be usable as an inert ingredient in pesticides due to its low toxicity
Status:
US Previously Marketed
Source:
21 CFR 310.528(a) aphrodisiac yohimbinum
Source URL:
First approved in 2015
Source:
NADA140866
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Yohimbine is a plant alkaloid with alpha-2-adrenergic blocking activity. Yohimbine has been used as a mydriatic and in the treatment of impotence. The exact mechanism for its use in impotence has not been fully elucidated. Yohimbine exerts antagonist actions at halpha(2A)-AR, h5-HT(1B), h5-HT(1D), and hD(2) sites, partial agonist actions at h5-HT(1A) sites. Yohimbine-mediated norepinephrine release at the level of the corporeal tissues may also be involved. In addition, beneficial effects may involve other neurotransmitters such as dopamine and serotonin and cholinergic receptors. Yohimbine has a mild anti-diuretic action, probably via stimulation of hypothalmic center and release of posterior pituitary hormone. Reportedly yohimbine exerts no significant influence on cardiac stimulation and other effects mediated by (beta)-adrenergic receptors. Its effect on blood pressure, if any, would be to lower it; however, no adequate studies are at hand to quantitate this effect in terms of Yohimbine dosage. Side effect of Yohimbine include anxiety, tremor, palpitations, diarrhea, and supine hypertension.