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Restrict the search for
amphotericin b
to a specific field?
Status:
US Approved Rx
(1959)
Source:
NDA011757
(1959)
Source URL:
First approved in 1957
Source:
NDA011153
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Methylprednisolone is a prednisolone derivative with similar anti-inflammatory and immunosuppressive action. It is adjunctive therapy for short-term administration in rheumatoid arthritis. It is indicated in the following conditions: endocrine disorders, rheumatic disorders, collagen diseases, allergic states etc. Methylprednisolone is marketed in the USA and Canada under the brand names Medrol and Solu-Medrol. Methylprednisolone is a GR receptor agonist.
Status:
US Approved Rx
(2013)
Source:
ANDA201507
(2013)
Source URL:
First approved in 1956
Source:
ATARAX by ROERIG
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Targets:
Conditions:
Hydroxyzine, a piperazine antihistamine structurally related to buclizine, cyclizine, and meclizine, is used to treat histamine-mediated pruritus or pruritus due to allergy, nausea and vomiting, and, in combination with an opiate agonist, anxiolytic pain. Hydroxyzine is also used as a perioperative sedative and anxiolytic and to manage acute alcohol withdrawal. Hydroxyzine competes with histamine for binding at H1-receptor sites on the effector cell surface, resulting in suppression of histaminic edema, flare, and pruritus. The sedative properties of hydroxyzine occur at the subcortical level of the CNS. Secondary to its central anticholinergic actions, hydroxyzine may be effective as an antiemetic. It is used for symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested.
Status:
US Approved Rx
(2009)
Source:
ANDA090097
(2009)
Source URL:
First approved in 1956
Source:
NDA010379
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Liothyronine (CYTOMEL®) is a T3 thyroid hormone normally synthesized and secreted by the thyroid gland in much smaller quantities than its prohormone thyroxine (T4). Most T3 is derived from peripheral monodeiodination of T4 at the 5' position of the outer ring of the iodothyronine nucleus. The hormone finally delivered and used by the tissues is mainly T3. The mechanisms by which thyroid hormones exert their physiologic action are not well understood. These hormones enhance oxygen consumption by most tissues of the body, increase the basal metabolic rate and the metabolism of carbohydrates, lipids, and proteins. Thus, they exert a profound influence on every organ system in the body and are of particular importance in the development of the central nervous system. Thyroid hormone drugs are indicated: as the replacement or supplemental therapy in patients with hypothyroidism of any etiology; as pituitary thyroid-stimulating hormone (TSH) suppressants, in the treatment or prevention of various types of euthyroid goiters; as diagnostic agents in suppression tests to differentiate suspected mild hyperthyroidism or thyroid gland autonomy.
Status:
US Approved Rx
(1964)
Source:
ANDA060593
(1964)
Source URL:
First approved in 1956
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Cycloserine was discovered simultaneously in 1954 by Eli Lilly and Merck. The drug was approved for the treatment of active pulmonary and extrapulmonary tuberculosis and marketed under the name Seromycin (among the others). Cycloserine suppresses the synthesis of bacterial wall by inhibitin two enzymes: alanine racemase and d-alanine ligase.
Status:
US Approved Rx
(1968)
Source:
ANDA060711
(1968)
Source URL:
First approved in 1955
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Penicillin V is a penicillin beta-lactam antibiotic used in the treatment of bacterial infections caused by susceptible, usually gram-positive, organisms. The name "penicillin" can either refer to several variants of penicillin available, or to the group of antibiotics derived from the penicillins. Penicillin V has in vitro activity against gram-positive and gram-negative aerobic and anaerobic bacteria. The bactericidal activity of Penicillin V results from the inhibition of cell wall synthesis and is mediated through Penicillin V binding to penicillin binding proteins (PBPs). Penicillin V is stable against hydrolysis by a variety of beta-lactamases, including penicillinases, and cephalosporinases and extended spectrum beta-lactamases. By binding to specific penicillin-binding proteins (PBPs) located inside the bacterial cell wall, Penicillin V inhibits the third and last stage of bacterial cell wall synthesis. Cell lysis is then mediated by bacterial cell wall autolytic enzymes such as autolysins; it is possible that Penicillin V interferes with an autolysin inhibitor. Used for the treatment of mild to moderately severe infections (e.g. dental infection, infections in the heart, middle ear infections, rheumatic fever, scarlet fever, skin infections, upper and lower respiratory tract infections) due to microorganisms.
Status:
US Approved Rx
(2023)
Source:
ANDA212383
(2023)
Source URL:
First approved in 1955
Class (Stereo):
CHEMICAL (ACHIRAL)
Dapsone was synthesized in 1908 by Fromm and Wittmann. The drug was approved by FDA for the treatment of such conditions as acne vulgaris, leprosy and dermatitis herpetiformis, also the drug is used off-label for many skin diseases. Although the exact mechanism of dapsone action is unknown, it is speculated that it acts as both anti-inflammatory and antimicrobial agent. It was demonstrated that dapsone suppresses ROS generation, inhibits neutrophil myeloperoxidase and eosinophil peroxidase and also inhibits bacterial dihydropteroate synthase.
Status:
US Approved Rx
(1993)
Source:
NDA020006
(1993)
Source URL:
First approved in 1955
Source:
Levsin by Alaven Pharmaceutical LLC
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Sorbitol is a polyhydric alcohol with about half the sweetness of sucrose. Sorbitol occurs naturally and is produced synthetically from glucose. It was formerly used as a diuretic and may still be used as a laxative and in irrigating solutions for some surgical procedures. Used as a non-stimulant laxative via an oral suspension or enema. Sorbitol exerts its laxative effect by drawing water into the large intestine, thereby stimulating bowel movements. Sorbitol plays a vital step in the 'polyol pathway'. The sudden injection of extra sorbitol can ruin the equilibrium of enzymes that regulate the conversion of glucose to fructose in a process associated with the onset of diabetes and its complications. Further, the polyol pathway is involved with a complex network of metabolic activities; disruption leads to a cascade of problems (citations here, here and here) such as mitochondrial failure, cell apoptosis (cell death), and DNA fragmentation. In general, sorbitol induces cell hyperosmotic stress resulting in phosphorylation (uptake of phosphorus into cell) — an important on/off switch regulating enzymes and signaling networks.
Status:
US Approved Rx
(1993)
Source:
NDA020006
(1993)
Source URL:
First approved in 1955
Source:
Levsin by Alaven Pharmaceutical LLC
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Sorbitol is a polyhydric alcohol with about half the sweetness of sucrose. Sorbitol occurs naturally and is produced synthetically from glucose. It was formerly used as a diuretic and may still be used as a laxative and in irrigating solutions for some surgical procedures. Used as a non-stimulant laxative via an oral suspension or enema. Sorbitol exerts its laxative effect by drawing water into the large intestine, thereby stimulating bowel movements. Sorbitol plays a vital step in the 'polyol pathway'. The sudden injection of extra sorbitol can ruin the equilibrium of enzymes that regulate the conversion of glucose to fructose in a process associated with the onset of diabetes and its complications. Further, the polyol pathway is involved with a complex network of metabolic activities; disruption leads to a cascade of problems (citations here, here and here) such as mitochondrial failure, cell apoptosis (cell death), and DNA fragmentation. In general, sorbitol induces cell hyperosmotic stress resulting in phosphorylation (uptake of phosphorus into cell) — an important on/off switch regulating enzymes and signaling networks.
Status:
US Approved Rx
(2020)
Source:
ANDA212541
(2020)
Source URL:
First approved in 1955
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Pyrazinamide is indicated for the initial treatment of active tuberculosis in adults and children when combined with other antituberculous agents. (The current recommendation of the CDC for drug-susceptible disease is to use a six-month regimen for initial treatment of active tuberculosis, consisting of isoniazid, rifampin and pyrazinamide given for 2 months, followed by isoniazid and rifampin for 4 months. Pyrazinamide should only be used in conjunction with other effective antituberculous agents. Pyrazinamide diffuses into M. tuberculosis, where the enzyme pyrazinamidase converts pyrazinamide to the active form pyrazinoic acid. Under acidic conditions, the pyrazinoic acid that slowly leaks out converts to the protonated conjugate acid, which is thought to diffuse easily back into the bacilli and accumulate. The net effect is that more pyrazinoic acid accumulates inside the bacillus at acid pH than at neutral pH. Pyrazinoic acid was thought to inhibit the enzyme fatty acid synthase (FAS) I, which is required by the bacterium to synthesise fatty acids. However, this theory was thought to have been discounted. However, further studies reproduced the results of FAS I inhibition as the putative mechanism first in whole cell assay of replicating M. tuberculosis bacilli which have shown that pyrazinoic acid and its ester inhibit the synthesis of fatty acids . This study was followed by in vitro assay of tuberculous FAS I enzyme that tested the activity with pyrazinamide, pyrazinoic acid and several classes of pyrazinamide analogs. Pyrazinamide and its analogs inhibited the activity of purified FAS I. It has also been suggested that the accumulation of pyrazinoic acid disrupts membrane potential and interferes with energy production, necessary for survival of M. tuberculosis at an acidic site of infection. Pyrazinoic acid has also been shown to bind to the ribosomal protein S1 (RpsA) and inhibit trans-translation. This may explain the ability of the drug to kill dormant mycobacteria
Status:
US Approved Rx
(2010)
Source:
ANDA091396
(2010)
Source URL:
First approved in 1955
Source:
DELTA-CORTEF by PHARMACIA AND UPJOHN
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Prednisolone hemisuccinate is a prodrug of a glucocorticoid agonist prednisolone, which is marketed under trade name Prednisolut in Germany and Austria. Prednisolone hemisuccinate is used in emergency medicine to treate shock due to allergic reaction, insect and snake bites, in neurology to treat brain edema and meningitis, in transplantation medicine to reduce risk of organ refection after kidney transplane, in pneumology to treat acute asthma attack, pulmonary edema, in severe or life-threatening situation in rheumatic diseases.