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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 Previously Marketed
Source:
21 CFR 310.545(a)(20) weight control lysine hydrochloride
Source URL:
First approved in 1971
Source:
NDA016822
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Lysing is an essential basic amino-acid encoded by codone AAA and AAG, and used in the biosynthesis of proteins. The daily requirement for lysine is 38 mg/kg body weight. The most rich source of lysine is fish, beef, chicken. In a clinical study lysine supplements was found to be an effective for reduction of occurrence, severity and healing time for recurrent HSV infection, however Cochrane Review concluded that the evidence is insufficient. Lysine was investigated for improving anxiety, ameliorating angina prectoris. Lysine acetylsalicylate has been used to treat pain and to detoxify the body after heroin use. Lysine clonixinate has been used for its analgesic properties for the treatment of migraine headaches and other painful conditions. However, limited clinical trials exist for these conditions.
Status:
US Previously Marketed
Source:
Stop-Zit by Nelson Baker & Company
(1962)
Source URL:
First approved in 1962
Source:
Stop-Zit by Nelson Baker & Company
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Denatonium, usually available as denatonium benzoate (trade names Bitrex) is the most bitter chemical compound known, with bitterness thresholds of 0.05 ppm for the benzoate and 0.01 ppm for the saccharide. Scientists at Macfarlan Smith, Ltd. of Edinburgh, Scotland discovered Bitrex during research on derivatives of the anesthetic lidocaine. The extremely bitter taste proved effective in reducing ingestion by humans and animals. Denatonium is commonly included in placebo medications used in clinical trials to match the bitter taste of certain medications. Denatonium activates bitter taste receptor, mainly, TAS2R4, TAS2R8, TAS2R10, TAS2R13 on many cell types and plays important roles in chemical release, ciliary beating and smooth muscle relaxation through intracellular Ca(2+)-dependent pathways.
Status:
First approved in 1960
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Chloroxylenol is used as a preservative in cooling fluids, cosmetics, topical medications, urinary antiseptics and metal working fluids. Products containing Chloroxylenol are used for cleaning and disinfecting wounds, abrasions and abscesses, for minor cuts and scratches, insect bites, burns, inflammation of the skin. It is also found in hair conditioners, toilet cleaners, deodorants, soaps and paste. New use cases continue to be identified. Chloroxylenol has been shown to be effective at reducing the number of pathogenic bacteria in clinical environments. Chloroxylenol has been reviewed and is permitted for use within the European Union (EU) in cosmetic products and is also permitted for use in a number of topical pharmaceutical products as licensed by the UK Medicines and Health Regulatory Agency. Chloroxylenol could cause mild skin irritation in some individuals, or cause an allergic reaction in others. Developed in Europe in the 1920s and used in the United States since the 1950s, Chloroxylenol is one of the most mature antimicrobial agents
Status:
First approved in 1957
Class (Stereo):
CHEMICAL (ABSOLUTE)
LEVAMFETAMINE the levorotatory form of amphetamine. L-amphetamine, is a central nervous system (CNS) stimulant known to increase wakefulness and concentration in association with decreased appetite and fatigue. Pharmaceuticals that contain levoamphetamine are currently indicated and prescribed for the treatment of attention deficit hyperactivity disorder (ADHD), obesity, and narcolepsy in some countries. L-Amphetamine succinate was sold in Hungary between 1952 and 1955 under the brand name Cydril.
Status:
US Previously Marketed
Source:
Precursone by Wyeth
(1951)
Source URL:
First approved in 1950
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Pregnenolone sulfate is an endogenous neurosteroid with excitatory effects in the brain, acting as a potent negative allosteric modulator of the GABAA receptor, a positive allosteric modulator of the NMDA receptor, and activator of transient receptor potential cation channel TRPM1 and TRPM3. In the model of schizophrenia, treatment with pregnenolone sulfate normalized the hyperlocomotion and stereotypic bouts, and rescued the PPI deficits of dopamine transporter knockout mice. Promnesic properties of pregnenolone sulfate were demonstrated in rat models of spatial memory performance.
Status:
US Previously Marketed
Source:
GLUTAVENE by TILDEN YATES
(1961)
Source URL:
First approved in 1939
Source:
FLANITHIN 325MG by TABLE ROCK
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Glutamic acid is a non-essential aminoacid used in biosynthesis of proteins. Besides being a building block of proteins, glutamic acid plays a principal role in neural activation. Glutamate is also responsible for the umami (savory) flavor of certain foods. In medicine, glutamate is used as a metabolic supplemnet in patients undergoing coronary surgery.
Status:
US Previously Marketed
Source:
ALLANTOMIDE SULFANILAMIDE by NATIONAL DRUG
(1961)
Source URL:
First marketed in 1936
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Sulfanilamide is an anibiotic drug, which has been used for decades for the treatment of vulvovaginal candidiasis. The drug blocks folic acid synthesis in bacterias by inhibitin the enzyme dihydropteroate synthase.
Status:
US Previously Marketed
Source:
ACR-ALLANTOMIDE AMINACRINE HYDROCHLORIDE by NATIONAL DRUG
(1961)
Source URL:
First marketed in 1934
Class (Stereo):
CHEMICAL (ACHIRAL)
Aminacrine has long been known to be a potent frameshift mutagen in viruses and bacteria. It is one in a general class of aminoacridine dyes that bind to DNA and possess mutagenic activity. Aminacrine is used clinically as a topical antiseptic. A part from therapeutic use, aminacrine is also introduced as a matrix for negative mode matrix-assisted laser desorption/ionization (MALDI).
Status:
US Previously Marketed
Source:
Silver Oxide U.S.P.
(1921)
Source URL:
First marketed in 1921
Class (Stereo):
CHEMICAL (RACEMIC)
Targets:
Conditions:
Silver iodide is an inorganic compound with the formula AgI. It is used as a photosensitive agent in photography, as a local antiseptic, as a chemical intermediate, and in cloud seeding for rain-making. The major hazards encountered in the use and handling of silver iodide stem from its toxicologic properties. Effects from exposure may include skin rashes, conjunctivitis, argyria (a permanent ashen-gray discoloration of skin, conjunctiva, and internal organs), headache, fever, hypersensitivity, laryngitis, and bronchitis.
Status:
US Previously Marketed
Source:
Silver Oxide U.S.P.
(1921)
Source URL:
First marketed in 1921
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Silver iodide is an inorganic compound with the formula AgI. It is used as a photosensitive agent in photography, as a local antiseptic, as a chemical intermediate, and in cloud seeding for rain-making. The major hazards encountered in the use and handling of silver iodide stem from its toxicologic properties. Effects from exposure may include skin rashes, conjunctivitis, argyria (a permanent ashen-gray discoloration of skin, conjunctiva, and internal organs), headache, fever, hypersensitivity, laryngitis, and bronchitis.