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Search results for "Established Pharmacologic Class [EPC]" in comments (approximate match)
Status:
US Approved Rx
(2011)
Source:
NDA022408
(2011)
Source URL:
First approved in 2011
Source:
NDA022408
Source URL:
Class:
MIXTURE
Conditions:
Spinosad is a natural mixture of pediculicidal tetracyclic macrolides—spinosyn A and spinosyn D in the ratio of 5:1. It is derived from species of actinomycetes bacteria - Saccharopolyspora spinosa and is a bacterial waste product produced by fermentation on a nutrient food source. It has since long been used as a pesticide and classified by the US Environment Protection Agency as a reduced risk pesticide product. Spinosad has a high level of efficacy for lepidopteran larvae, as well as some Diptera, Coleoptera, Thysanoptera, and Hymenoptera, but has limited to no activity to other insects and exhibits low toxicity to mammals and other wildlife. Spinosad overstimulates nerve cells by prolonging electrical impulse across synapses by acting like acetylcholine. After periods of hyperexcitation, lice become paralyzed and die. Recently, FDA has approved the topical suspension of spinosad 0.9% for treatment of head lice infestation in patients four years of age and older. It is both pediculicidal and ovicidal.
Status:
US Approved Rx
(2014)
Source:
ANDA200910
(2014)
Source URL:
First approved in 2001
Source:
ORTHO EVRA by JANSSEN PHARMS
Source URL:
Class:
MIXTURE
Targets:
Conditions:
Norelgestromin, the progestin, is the active metabolite of norgestimate and is structurally related to 19-nortestosterone. Norgestimate and norelgestromin mimic the physiologic effects of progesterone at the progesterone receptor. Johnson & Johnson developed an adhesive female contraceptive patch that contains ethinylestradiol (0.75mg) and the progestogen norelgestromin (6mg). his product is a combination contraceptive acting via the inhibition gonadotropins. Its primary mechanism of action involves the suppression of ovulation, including changes in the cervical mucus and endometrium. The patch delivers a continuous flow of hormones through the skin and into the bloodstream. The contraceptive patch is available in countries worldwide.
Status:
US Approved Rx
(2000)
Source:
NDA021119
(2000)
Source URL:
First approved in 2000
Source:
NDA021119
Source URL:
Class:
MIXTURE
Conditions:
Verteporfin (trade name Visudyne), a benzoporphyrin derivative, is a medication used for the treatment of patients with predominantly classic subfoveal choroidal neovascularization due to age-related macular degeneration, pathologic myopia or presumed ocular histoplasmosis syndrome. Verteporfin can also be used to destroy tumors. Verteporfin is a 1:1 mixture of two regioisomers (I and II), VISUDYNE therapy is a two-stage process requiring administration of both verteporfin for injection and nonthermal red light. Verteporfin accumulates in these abnormal blood vessels and, when stimulated by nonthermal red light with a wavelength of 689 nm in the presence of oxygen, produces highly reactive short-lived singlet oxygen and other reactive oxygen radicals, resulting in local damage to the endothelium and blockage of the vessels. Verteporfin is also used off-label for the treatment of central serous retinopathy. Verteporfin is given intravenously, 15 minutes before laser treatment. Light activation of verteporfin results in local damage to neovascular endothelium, resulting in vessel occlusion. Damaged endothelium is known to release procoagulant and vasoactive factors through the lipo-oxygenase (leukotriene) and cyclo-oxygenase (eicosanoids such as thromboxane) pathways, resulting in platelet aggregation, fibrin clot formation and vasoconstriction. Verteporfin appears to somewhat preferentially accumulate in neovasculature, including choroidal neovasculature. However, animal models indicate that the drug is also present in the retina. Therefore, there may be collateral damage to retinal structures following photoactivation including the retinal pigmented epithelium and outer nuclear layer of the retina. The temporary occlusion of choroidal neovascularization (CNV) following VISUDYNE therapy has been confirmed in humans by fluorescein angiography.
Status:
US Approved Rx
(2020)
Source:
ANDA210834
(2020)
Source URL:
First approved in 1997
Source:
NaturVet ArthriSoothe by The Garmon Corporation
Source URL:
Class:
MIXTURE
Status:
US Approved Rx
(1991)
Source:
BLA020032
(1991)
Source URL:
First approved in 1991
Source:
BLA020032
Source URL:
Class:
MIXTURE
Status:
US Approved Rx
(2015)
Source:
ANDA200383
(2015)
Source URL:
First approved in 1989
Source:
ORTHO CYCLEN-21 by JANSSEN PHARMS
Source URL:
Class:
MIXTURE
Targets:
Norgestimate is a steroidal progestin of the 19-nortestosterone group that is used in combination with ethinylestradiol as an oral contraceptive and for treatment of acne. and in combination with estradiol in menopausal hormone replacement therapy. Norgestimate shows high selectivity for the progesterone receptor and low androgenic activity.
Status:
US Approved Rx
(1989)
Source:
BLA103158
(1989)
Source URL:
First approved in 1989
Source:
BLA103158
Source URL:
Class:
MIXTURE
Status:
US Approved Rx
(2000)
Source:
ANDA075014
(2000)
Source URL:
First approved in 1986
Source:
NIX by GLAXOSMITHKLINE
Source URL:
Class:
MIXTURE
Targets:
Permethrin is a synthetic pyrethrin derivative acts as a neurotoxin by depolarizing the nerve cell membrane. Permethrin disrupts the sodium channel current by which membrane repolarization is regulated resulting in fatal paralysis of the nerves in the exoskeletal respiratory muscles of susceptible arthropods, including lice and mite. Permethrin is sold under brand names NIx and Elimite to treat pediculosis, scabies and demodicidosis.
Status:
US Approved Rx
(1989)
First approved in 1986
Class:
MIXTURE
Status:
US Approved Rx
(2002)
Source:
BLA021484
(2002)
Source URL:
First approved in 1986
Source:
METRODIN by SERONO
Source URL:
Class:
MIXTURE