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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
(2019)
Source:
ANDA206455
(2019)
Source URL:
First approved in 1997
Source:
NaturVet ArthriSoothe by The Garmon Corporation
Source URL:
Class:
MIXTURE
Status:
US Approved Rx
(2016)
Source:
NDA207648
(2016)
Source URL:
First approved in 1997
Source:
NaturVet ArthriSoothe by The Garmon Corporation
Source URL:
Class:
MIXTURE
Status:
US Approved Rx
(1996)
Source:
NDA020532
(1996)
Source URL:
First approved in 1996
Source:
NDA020532
Source URL:
Class:
MIXTURE
Status:
US Approved Rx
(2021)
Source:
ANDA209708
(2021)
Source URL:
First approved in 1992
Source:
MIVACRON by ABBVIE
Source URL:
Class:
MIXTURE
Conditions:
Mivacurium chloride (Mivacron) is a new benzylisoquinolinium choline-like diester neuromuscular blocking drug with an onset of action at equipotent doses that is comparable to atracurium and vecuronium but slower than succinylcholine. MIVACRON (a mixture of three stereoisomers) binds competitively to cholinergic receptors on the
motor end-plate to antagonize the action of acetylcholine, resulting in a block of neuromuscular
transmission. This action is antagonized by acetylcholinesterase inhibitors, such as neostigmine. MIVACRON is a short-acting neuromuscular blocking agent indicated for inpatients and outpatients,
as an adjunct to general anesthesia, to facilitate tracheal intubation and to provide skeletal muscle
relaxation during surgery or mechanical ventilation.
Status:
US Approved Rx
(2006)
Source:
NDA021902
(2006)
Source URL:
First approved in 1992
Source:
21 CFR 358A
Source URL:
Class:
MIXTURE
Status:
US Approved Rx
(2012)
Source:
ANDA065351
(2012)
Source URL:
First approved in 1991
Source:
CEFZIL by CORDEN PHARMA
Source URL:
Class:
MIXTURE
Targets:
Conditions:
Cefprozil is a 2nd generation cephalosporin that is FDA approved for the treatment of mild to moderate infections of upper respiratory tract, lower respiratory tract, and uncomplicated skin and skin-structure infections. Cefprozil, like the penicillins, is a beta-lactam antibiotic. By binding to specific penicillin-binding proteins (PBPs) located inside the bacterial cell wall, it inhibits the third and last stage of bacterial cell wall synthesis. Common adverse reactions include diarrhea, nausea, vomiting, dizziness, abdominal pain and vaginitis. Nephrotoxicity has been reported following concomitant administration of aminoglycoside antibiotics and cephalosporin antibiotics. Concomitant administration of probenecid doubled the AUC for cefprozil.
Status:
US Approved Rx
(1991)
Source:
BLA020032
(1991)
Source URL:
First approved in 1991
Source:
BLA020032
Source URL:
Class:
MIXTURE
Status:
US Approved Rx
(2005)
Source:
ANDA076812
(2005)
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