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Status:
US Previously Marketed
Source:
TONOCARD by ASTRAZENECA
(1984)
Source URL:
First approved in 1984
Source:
TONOCARD by ASTRAZENECA
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Targets:
Conditions:
Tocainide is a primary amine analog of lidocaine with antiarrhythmic properties useful in the treatment of ventricular arrhythmias. Tocainide, like lidocaine, produces dose-dependent decreases in sodium and potassium conductance, thereby decreasing the excitability of myocardial cells. In experimental animal models, the dose-related depression of sodium current is more pronounced in ischemic tissue than in normal tissue. Tocainide is a Class I antiarrhythmic compound with electrophysiologic properties in man similar to those of lidocaine, but dissimilar from quinidine, procainamide, and disopyramide. The recommended initial dosage is 400 mg every 8 hours. The usual adult dosage is between 1200 and 1800 mg/day in a three-dose daily divided regimen. Doses beyond 2400 mg per day have been administered infrequently. Patients who tolerate the t.i.d. the regimen may be tried on a twice-daily regimen with careful monitoring. Tocainide commonly produces minor, transient, nervous system and gastrointestinal adverse reactions, but is otherwise generally well tolerated.
Status:
US Previously Marketed
Source:
MODRASTANE by BIOENVISION
(1984)
Source URL:
First approved in 1984
Source:
MODRASTANE by BIOENVISION
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Trilostane is a synthetic steroid, which interferes with the formation of both cortisol and aldosterone. It is an inhibitor of 3 beta-hydroxysteroid dehydrogenase. This drug under trade name MODRASTANE was withdrawn from human use in the United States market. But marketed under the trade names Modrenal and is already approved in the United Kingdom for the treatment of advanced post-menopausal breast cancer and Cushing 's disease. In addition, this drug has been successfully developed and marketed for veterinary use in the United Kingdom under the trade name Vetoryl.
Status:
US Previously Marketed
Source:
PRECEF by BRISTOL
(1984)
Source URL:
First approved in 1984
Source:
PRECEF by BRISTOL
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Ceforanide is a new cephalosporin with a longer elimination half-life than any currently available cephalosporin. Its activity is very similar to that of cefamandole, a second-generation cephalosporin, except that ceforanide is less active against most gram-positive organisms. The bactericidal activity of ceforanide results from the inhibition of cell wall synthesis via affinity for penicillin-binding proteins (PBPs). Ceforanide is primarily indicated in conditions like bone and joint infection, endocarditis, respiratory tract infections, skin infections, surgical infections, urinary tract infection. Rash and pruritus, and nausea, vomiting and other mild gastrointestinal side effects were noted in a few of the subjects but were mild and transient.
Status:
US Previously Marketed
Source:
EXOSURF NEONATAL by GLAXOSMITHKLINE
(1990)
Source URL:
First approved in 1984
Source:
NU-DERM SUNFADER Skin Lightener with Sunscreen (SPF 15) PABA FREE by OMP, INC.
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Cetyl alcohol is the 16-carbon alcohol corresponding to palmitic acid, so called because it is isolated from among the hydrolysis products of spermaceti. This medication is used as a moisturizer to treat or prevent dry, rough, scaly, itchy skin and minor skin irritations (e.g., diaper rash, skin burns from radiation therapy). Most emollients can be used safely and effectively with no side effects. However, burning, stinging, redness, or irritation may occur. A very serious allergic reaction to this drug is rare.
Status:
US Previously Marketed
Source:
TRASICOR by NOVARTIS
(1983)
Source URL:
First approved in 1983
Source:
TRASICOR by NOVARTIS
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Targets:
Oxprenolol is clinically a well-established beta blocker that shares with other members of this group the ability to control a variety of disorders, in particular, hypertension and angina. Pharmacologically it is a nonselective beta blocker that possesses partial agonist activity (intrinsic sympathomimetic activity). Pharmacokinetically, oxprenolol behaves as a moderately lipophilic agent. Oxprenolol undergoes first pass metabolism with only 30% of an oral dose reaching the systemic circulation. The drug is approximately 80% protein bound and is eliminated primarily by glucuronidation in the liver. Less than 4% of oxprenolol is excreted unchanged in the urine. Oxprenolol may reduce the heart rate and prolong the effective and functional atrioventricular nodal refractory period. Oxprenolol has less negative inotropic and chronotropic effects than propranolol. Plasma renin activity is reduced; however, changes in plasma aldosterone level are not significant. Long term metabolic effects require further study. Chest pain (angina), high blood pressure (hypertension), irregular heart beats and anxiety are indications for Oxprenolol usage. To date Oxprenolol is discontinued by FDA.
Status:
US Previously Marketed
Source:
21 CFR 310.545(a)(18)(vi)(A) skin protectant:poison ivy/oak/sumac cetalkonium chloride
Source URL:
First approved in 1983
Source:
NDA214965
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Cetalkonium chloride is a cationic quaternary ammonium surfactant, which is used for the treatment of mouth ulcers and sores (Bonjela trade name). It is also serves as an excipient for the purpose of long-term stabilization of ciclosporin ocular formulation, used in patients with dry eye syndrom (Ikervis trade name). The antibacterial properties of cetalkonium can be explained by its detergent character. Once applied, cetalkonium blocks the survival of biofilm forming bacterias.
Status:
US Previously Marketed
Source:
CHYMEX by SAVAGE LABS
(1983)
Source URL:
First approved in 1983
Source:
CHYMEX by SAVAGE LABS
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Bentiromide (Chymex) is a diagnostic agent that was approved for the diagnosis of pancreatic exocrine insufficiency. It is given by mouth as a noninvasive test. The amount of p-aminobenzoic acid and its metabolites excreted in the urine is taken as a measure of the chymotrypsin-secreting activity of the pancreas. Headache and gastrointestinal disturbances have been reported in patients taking bentiromide. Bentiromide is not available in the United States or Canada.
Status:
US Previously Marketed
Source:
CEFIZOX by ASTELLAS
(1994)
Source URL:
First approved in 1983
Source:
CEFIZOX by ASTELLAS
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Ceftizoxime is a semisynthetic cephalosporin antibiotic, which can be administered intravenously or intramuscularly. It was sold under brand name, cefizox, but was removed from the US Market in 2007. Cefizox was used to treat different infections, such as lower respiratory tract infections caused by Klebsiella spp.; Proteus mirabilis; Escherichia coli; Haemophilus influenza; urinary tract Infections caused by Staphylococcus aureus (penicillinase¬ and nonpenicillinase¬producing); Escherichia coli; Pseudomonas spp. Also for treatment of gonorrhea including uncomplicated cervical and urethral gonorrhea caused by Neisseria gonorrhoeae; pelvic inflammatory disease caused by Neisseria gonorrhoeae, Escherichia coli or Streptococcus agalactiae; meningitis caused by Haemophilus influenza. In addition, some others infections. Cefizox has also been used successfully in the treatment of a limited number of pediatric and adult cases of meningitis caused by Streptococcus pneumoniae. Infections caused by aerobic gram ¬negative and by mixtures of organisms resistant to other cephalosporins, aminoglycosides, or penicillins have responded to treatment with Cefizox. The bactericidal action of ceftizoxime results from inhibition of the third and last stage of bacterial cell wall synthesis. Bacterial cell wall autolytic enzymes such as autolysins then mediate cell lysis; it is possible that ceftizoxime interferes with an autolysin inhibitor. Ceftizoxime is highly resistant to a broad spectrum of beta -lactamases (penicillinase and cephalosporinase), including Richmond types II, III, TEM, IV, produced by both aerobic and anaerobic gram - positive and gram - negative organisms and I.
Status:
US Previously Marketed
Source:
NETROMYCIN by SCHERING
(1983)
Source URL:
First approved in 1983
Source:
NETROMYCIN by SCHERING
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Netilmicin is a semisynthetic, water soluble antibiotic of the aminoglycoside group, produced by the fermentation of Micromonospora inyoensis, a species of actinomycete. Aminoglycosides are useful primarily in infections involving aerobic, Gram-negative bacteria, such as Pseudomonas, Acinetobacter, and Enterobacter. It is active at low concentrations against a wide variety of pathogenic bacteria including Escherichia coli, bacteria of the Klebsiella-Enterobacter-Serratia group, Citrobacter sp., Proteus sp. (indole-positive and indole-negative), including Proteus mirabilis, P. morganii, P. rettgrei, P. vulgaris, Pseudomonas aeruginosa and Neisseria gonorrhoea. Netilmicin is also active in vitro against isolates of Hemophilus influenzae, Salmonella sp., Shigella sp. and against penicillinase and non-penicillinase-producing Staphylococcus including methicillin-resistant strains. Some strains of Providencia sp., Acinetobacter sp. and Aeromonas sp. are also sensitive to netilmicin. Many strains of the above organisms which are found to be resistant to other aminoglycosides, such as kanamycin, gentamicin, tobramycin and sisomicin, are susceptible to netilmicin in vitro. Occasionally, strains have been identified which are resistant to amikacin but susceptible to netilmicin. The combination of netilmicin and penicillin G has a synergistic bactericidal effect against most strains of Streptococcus faecalis (enterococcus). The combined effect of netilmicin and carbenicillin or ticarcillin is synergistic for many strains of Pseudomonas aeruginosa. In addition, many isolates of Serratia, which are resistant to multiple antibiotics, are inhibited by synergistic combinations of netilmicin with carbenicillin, azlocillin, mezlocillin, cefamandole, cefotaxime or moxalactam. Netilmicin "irreversibly" binds to specific 30S-subunit proteins and 16S rRNA. Specifically netilmicin binds to four nucleotides of 16S rRNA and a single amino acid of protein S12. This interferes with decoding site in the vicinity of nucleotide 1400 in 16S rRNA of 30S subunit. This region interacts with the wobble base in the anticodon of tRNA. This leads to interference with the initiation complex, misreading of mRNA so incorrect amino acids are inserted into the polypeptide leading to nonfunctional or toxic peptides and the breakup of polysomes into nonfunctional monosomes, leaving the bacterium unable to synthesize proteins vital to its growth.
Status:
US Previously Marketed
Source:
AZLIN by BAYER PHARMS
(1982)
Source URL:
First approved in 1982
Source:
AZLIN by BAYER PHARMS
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Azlocillin is a semisynthetic penicillin with broad spectrum of anti-bacterial action. The drug is effective against gram-negative and gram-positive infections and acts by inhibition of penicillin-binding protein (PBP)-dependent bacterial cell wall synthesis. Azlocillin was marketed in the USA under the name Azlin (sodium salt), however, its approval was discontinued.