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Status:
US Previously Marketed
Source:
DORIBAX by SHIONOGI INC
(2007)
Source URL:
First approved in 2007
Source:
DORIBAX by SHIONOGI INC
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Doripenem is a synthetic carbapenem that has broad antibacterial potency against aerobic and anaerobic gram-positive and gram-negative bacteria. Doripenem is structurally related to beta-lactam antibiotics and shares the bactericidal mode of action of other β-lactam antibiotics by targeting penicillin-binding proteins (PBPs) to inhibit the biosynthesis of the bacterial cell wall. Doripenem is resistant to hydrolysis by most β-lactamases and is resistant to inactivation by renal dehydropeptidases. Doripenem has many similarities to the other carbapenems, as well as some important differences, such as greater potency against Pseudomonas aeruginosa. It was found to be similar to comparator agents. The most common adverse effects related to doripenem therapy were headache, nausea, diarrhea, rash, and phlebitis.
Status:
Possibly Marketed Outside US
First approved in 2007
Source:
DHA by Exeltis USA, Inc
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Doconexent (Docosahexaenoic acid, DHA) is an omega-3 fatty acid that is a primary structural component of the human brain, cerebral cortex, skin, and retina. DHA is widely used as a food supplement, and is beleived to support healthy brain development in young childred, prevent cardiovascular disease and cognitive decline during Alzheimer's disease. Most of these claims, however, were not supported by clinical trials. DHA spray is used as a tanner.
Status:
Possibly Marketed Outside US
Source:
21 CFR 352
(2019)
Source URL:
First approved in 2007
Source:
21 CFR 358H
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Status:
Possibly Marketed Outside US
Source:
21 CFR 346
(2020)
Source URL:
First approved in 2007
Source:
21 CFR 348
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Status:
Possibly Marketed Outside US
First approved in 2007
Source:
Fosteum by Primus Pharmaceuticals, Inc.
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
GENISTEIN is an isoflavonoid derived from soy products. It inhibits protein-tyrosine kinase and topoisomerase-II (DNA topoisomerases, type II) activity and is used as an antineoplastic and antitumor agent. Experimentally, it has been shown to induce G2 phase arrest in human and murine cell lines. Additionally, genistein has antihelmintic activity. It has been determined to be the active ingredient in Felmingia vestita, which is a plant traditionally used against worms. It has also been demonstrated to be effective against intestinal parasites such as the common liver fluke, pork trematode and poultry cestode. Further, genistein is a phytoestrogen which has selective estrogen receptor modulator properties. It has been investigated in clinical trials as an alternative to classical hormone therapy to help prevent cardiovascular disease in postmenopausal women. Genistein can be found in food sources such as tofu, fava beans, soybeans, kudzu, and lupin. It is also present in certain cell cultures and medicinal plants.
Status:
Possibly Marketed Outside US
Source:
21 CFR 352
(2019)
Source URL:
First approved in 2007
Source:
21 CFR 358H
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Status:
Possibly Marketed Outside US
Source:
21 CFR 352
(2012)
Source URL:
First approved in 2007
Source:
21 CFR 352
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Erythorbic acid, an epimer of L-ascorbic acid, is used in the United States as a food additive. It was studied, that erythorbic acid enhanced of iron absorption and could play a major role in enhancing iron bioavailability from mixed diets that include foods preserved with erythorbic acid. In addition, was investigated if the erythorbic acid could influence on the metabolism of vitamin C in young women, and obtained results showed, that prolonged ingestion of erythorbic acid had no effect on vitamin C uptake or clearance from the body.
Status:
Possibly Marketed Outside US
First approved in 2007
Source:
NADA141273
Source URL:
Class (Stereo):
CHEMICAL (UNKNOWN)
Conditions:
Pimobendan (INN, or pimobendane; tradenames Vetmedin, Acardi, and Heartmedin) is a veterinary medication. Under the trade name Acardi, it is available for human use in Japan. Usually, this medicine is used to treat acute heart failure and chronic heart failure (mild to moderate in severity). By increasing the calcium ion sensitivity to protein regulating myocardial contraction and also by inhibiting phosphodiesterase (PDE-III) activity, this medicine dilates the blood vessels and improves the symptoms of heart failure such as shortness of breath and difficulty in breathing. Pimobendan is metabolized into an active metabolite (desmethylpimobendan) by the liver. The parent compound, pimobendan, is a potent calcium sensitizer while desmethylpimobendan is a more potent phosphodiesterase III inhibitor. Pimobendan is 90–95% bound to plasma proteins in circulation. This may have implications in patients suffering from low blood protein levels (hypoproteinemia/hypoalbuminemia) and in patients that are on concurrent therapies that are also highly protein bound.
Status:
Possibly Marketed Outside US
First approved in 2007
Source:
NADA141273
Source URL:
Class (Stereo):
CHEMICAL (UNKNOWN)
Conditions:
Pimobendan (INN, or pimobendane; tradenames Vetmedin, Acardi, and Heartmedin) is a veterinary medication. Under the trade name Acardi, it is available for human use in Japan. Usually, this medicine is used to treat acute heart failure and chronic heart failure (mild to moderate in severity). By increasing the calcium ion sensitivity to protein regulating myocardial contraction and also by inhibiting phosphodiesterase (PDE-III) activity, this medicine dilates the blood vessels and improves the symptoms of heart failure such as shortness of breath and difficulty in breathing. Pimobendan is metabolized into an active metabolite (desmethylpimobendan) by the liver. The parent compound, pimobendan, is a potent calcium sensitizer while desmethylpimobendan is a more potent phosphodiesterase III inhibitor. Pimobendan is 90–95% bound to plasma proteins in circulation. This may have implications in patients suffering from low blood protein levels (hypoproteinemia/hypoalbuminemia) and in patients that are on concurrent therapies that are also highly protein bound.
Status:
Possibly Marketed Outside US
First approved in 2007
Source:
NADA141273
Source URL:
Class (Stereo):
CHEMICAL (UNKNOWN)
Conditions:
Pimobendan (INN, or pimobendane; tradenames Vetmedin, Acardi, and Heartmedin) is a veterinary medication. Under the trade name Acardi, it is available for human use in Japan. Usually, this medicine is used to treat acute heart failure and chronic heart failure (mild to moderate in severity). By increasing the calcium ion sensitivity to protein regulating myocardial contraction and also by inhibiting phosphodiesterase (PDE-III) activity, this medicine dilates the blood vessels and improves the symptoms of heart failure such as shortness of breath and difficulty in breathing. Pimobendan is metabolized into an active metabolite (desmethylpimobendan) by the liver. The parent compound, pimobendan, is a potent calcium sensitizer while desmethylpimobendan is a more potent phosphodiesterase III inhibitor. Pimobendan is 90–95% bound to plasma proteins in circulation. This may have implications in patients suffering from low blood protein levels (hypoproteinemia/hypoalbuminemia) and in patients that are on concurrent therapies that are also highly protein bound.