U.S. Department of Health & Human Services Divider Arrow National Institutes of Health Divider Arrow NCATS

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Showing 221 - 230 of 311 results

Status:
US Approved OTC
Source:
21 CFR 349.12(b) ophthalmic:demulcents dextran 70
Source URL:
First approved in 1953
Source:
Dextran 70 6% in 0.9% Sodium Chloride by American McGaw
Source URL:

Class:
POLYMER

structurally diverse
Status:
US Approved Rx (1998)
Source:
BLA103777
(1998)
Source URL:
First approved in 1971
Source:
BLA101141
Source URL:

Class:
STRUCTURALLY DIVERSE

structurally diverse
Status:
US Approved Rx (2000)
Source:
BLA103941
(2000)
Source URL:

Class:
STRUCTURALLY DIVERSE

structurally diverse
Status:
US Approved Rx (2009)
Source:
BLA125329
(2009)
Source URL:
First approved in 1944
Source:
BLA101134
Source URL:

Class:
STRUCTURALLY DIVERSE


Immune globulin human (Human immunoglobulin) is a mixture of IgG1 and other antibodies derived from healthy human plasma and used to strengthen the body's natural defense system (immune system) to reduce the risk of infection in people with weakened immune systems. Human immunoglobulin is used as replacement therapy for inherited humoral immunodeficiency disorders, such as severe combined immunodeficiency syndrome, x-linked agammaglobulinemia, and Wiskott-Aldrich syndrome. Human immunoglobulin interacts with a number of different components of the immune system, including cytokines, complement, Fc receptors, and several immunocompetent cell surface molecules. Human immunoglobulin also acts on various effector cells of the immune system (B and T lymphocytes, dendritic cells, etc.) and regulates a wide range of genes. Human immune globulin competitively blocks gamma Fc receptors, preventing the binding and ingestion of phagocytes and inhibiting platelet depletion. Human immunoglobulin contains a number of different antibodies that prevent infection by attaching pathogenic microorganisms to the surface and facilitating their removal before they can infect cells. Antibodies remove pathogens by activating complement, agglutination or precipitation, blocking the pathogen receptor, “tagging” macrophages, or neutralizing the pathogen toxins. Serious adverse reactions are observed during intravenous treatment in clinical studies of aseptic meningitis. The most common adverse reactions were headache, fatigue, hyperthermia, nausea, chills, severity, pain in the limbs, diarrhea, migraine, dizziness, vomiting, cough, urticaria, asthma, sore throat and throat, rash, myalgia, itching, and cardiac murmur. During clinical trials of subcutaneous treatment, no serious adverse reactions were observed.
structurally diverse
Status:
US Approved OTC
Source:
21 CFR 358.710(c)(1) dandruff:psoriasis coal tar
Source URL:
First marketed in 1921

Class:
STRUCTURALLY DIVERSE

structurally diverse
Status:
US Previously Marketed
Source:
21 CFR 310.545(a)(8)(ii) digestive aid senna
Source URL:

Class:
STRUCTURALLY DIVERSE

structurally diverse
Status:
US Previously Marketed
Source:
21 CFR 310.545(a)(12)(iv)(A) laxative:stimulant laxative podophyllum resin (podophyllin)
Source URL:
First approved in 1990

Class:
STRUCTURALLY DIVERSE


Podophyllum resin is the powdered mixture of resins removed from the May apple or Mandrake, a perennial plant of the northern and middle United States. The early colonists learned of themedical properties of the root from the Indians, and it was used as a cathartic in the firstUnited States Pharmacopoeia (1820). The resin, podophyllin, was first separated from Podophyllum by John King in 1835. Between 1863 and 1942, podophyllin was reported to be a cathartic, purgative, deobstruent, vermifuge, hydragogue, cholagogue, choleretic, andexpectorant.Itwas recommended, either alone or in combination with other herbs, for diseases of the liverandkidneys, for scrofula, syphilis, gonorrhea, obstructed menstruation, urinary obstruction, dropsy, and coughs. Currently Podophyllum resin is used as a medication to treat genital warts and plantar warts, including in people with HIV/AIDS. Common side effects include redness, itchiness, and pain at the site of use. Severe side effects may include vomiting, abdominal pain, confusion, bone marrow suppression, and diarrhea. It is not recommended for more than a small area at a time. Use during pregnancy is known to be dangerous to the baby.
Artenimol (dihydroartemisinin) is a derivate of antimalarial compound artemisinin. Artenimol (dihydroartemisinin) is able to reach high concentrations within the parasitized erythrocytes. Its endoperoxide bridge is thought to be essential for its antimalarial activity, causing free-radical damage to parasite membrane systems including: • Inhibition of falciparum sarcoplasmic-endoplasmic reticulum calcium ATPase, • Interference with mitochondrial electron transport • Interference with parasite transport proteins • Disruption of parasite mitochondrial function. Dihydroartemisinin in combination with piperaquine tetraphosphate (Eurartesim, EMA-approved in 2011) is indicated for the treatment of uncomplicated Plasmodium falciparum malaria. The formulation meets WHO recommendations, which advise combination treatment for Plasmodium falciparum malaria to reduce the risk of resistance development, with artemisinin-based preparations regarded as the ‘policy standard’. However, experimental testing demonstrates that, due to its intrinsic chemical instability, dihydroartemisinin is not suitable to be used in pharmaceutical formulations. In addition, data show that the currently available dihydroartemisinin preparations fail to meet the internationally accepted stability requirements.
Artemether is an antimalarial agent used to treat acute uncomplicated malaria. It is administered in combination with lumefantrine for improved efficacy against malaria. Artemether is rapidly metabolized into an active metabolite dihydroartemisinin (DHA). The antimalarial activity of artemether and DHA has been attributed to endoperoxide moiety. Artemethe involves an interaction with ferriprotoporphyrin IX (“heme”), or ferrous ions, in the acidic parasite food vacuole, which results in the generation of cytotoxic radical species. The generally accepted mechanism of action of peroxide antimalarials involves interaction of the peroxide-containing drug with heme, a hemoglobin degradation byproduct, derived from proteolysis of hemoglobin. This interaction is believed to result in the formation of a range of potentially toxic oxygen and carbon-centered radicals. Other mechanisms of action for artemether include their ability to reduce fever by production of signals to hypothalamus thermoregulatory center. Now, recent research has shown the presence of a new, previously unknown cyclooxygenase enzyme COX-3, found in the brain and spinal cord, which is selectively inhibited by artemether, and is distinct from the two already known cyclooxygenase enzymes COX-1 and COX-2. It is now believed that this selective inhibition of the enzyme COX-3 in the brain and spinal cord explains the ability of artemether in relieving pain and reducing fever which is produced by malaria. The most common adverse reactions in adults (>30%) are headache, anorexia, dizziness, asthenia, arthralgia and myalgia.

Class (Stereo):
CHEMICAL (RACEMIC)

Targets:

Conditions:

Lumefantrine is an antimalarial agent used to treat acute uncomplicated malaria. It is administered in combination with artemether for improved efficacy (Coartem tablets). Lumefantrine is a blood schizonticide active against erythrocytic stages of Plasmodium falciparum. The exact mechanism by which lumefantrine exerts its antimalarial effect is unknown. The most common adverse reactions of Coartem in adults are headache, anorexia, dizziness, asthenia, arthralgia and myalgia.

Showing 221 - 230 of 311 results