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Restrict the search for
m fenfluramine
to a specific field?
Status:
US Approved Rx
(2013)
Source:
NDA203389
(2013)
Source URL:
First approved in 1994
Source:
NDA020392
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Cysteamine (trade name CYSTAGON) is a cystine-depleting agent indicated for the treatment of corneal cystine crystal accumulation in patients with cystinosis. Cystinosis is an autosomal recessive inborn error of metabolism in which the transport of cystine out of lysosomes is abnormal; in the nephropathic form, accumulation of cystine and formation of crystals damage various organs, especially the kidney, leading to renal tubular Fanconi Syndrome and progressive glomerular failure, with end-stage renal failure by the end of the first decade of life. In four studies of cystinosis patients before cysteamine was available, renal death (need for transplant or dialysis) occurred at the median age of fewer than 10 years. Patients with cystinosis also experience growth failure, rickets, and photophobia due to cystine deposits in the cornea. With time most organs are damaged, including the retina, muscles and central nervous system. Cysteamine is an aminothiol that participates within lysosomes in a thiol-disulfide interchange reaction converting cystine into cysteine and cysteine-cysteamine mixed disulfide, both of which can exit the lysosome in patients with cystinosis.
Status:
US Approved Rx
(2003)
Source:
ANDA075992
(2003)
Source URL:
First approved in 1994
Source:
NAVELBINE by PIERRE FABRE
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Vinorelbine (trade name Navelbine) is a semi-synthetic vinca-alkaloid with a broad spectrum
of anti-tumour activity. Vinorelbine is a mitotic spindle poison that impairs chromosomal segregation during mitosis. It blocks cells at G2/M. Microtubules (derived from polymers of tubulin) are the principal target of vinorelbine. Vinorelbine was developed by Pierre Fabre under licence from the CNRS in France. NAVELBINE (vinorelbine tartrate) as a single agent or in combination is indicated for the first line treatment of non small cell lung cancer and advanced breast cancer.
Status:
US Approved Rx
(2013)
Source:
NDA203389
(2013)
Source URL:
First approved in 1994
Source:
NDA020392
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Cysteamine (trade name CYSTAGON) is a cystine-depleting agent indicated for the treatment of corneal cystine crystal accumulation in patients with cystinosis. Cystinosis is an autosomal recessive inborn error of metabolism in which the transport of cystine out of lysosomes is abnormal; in the nephropathic form, accumulation of cystine and formation of crystals damage various organs, especially the kidney, leading to renal tubular Fanconi Syndrome and progressive glomerular failure, with end-stage renal failure by the end of the first decade of life. In four studies of cystinosis patients before cysteamine was available, renal death (need for transplant or dialysis) occurred at the median age of fewer than 10 years. Patients with cystinosis also experience growth failure, rickets, and photophobia due to cystine deposits in the cornea. With time most organs are damaged, including the retina, muscles and central nervous system. Cysteamine is an aminothiol that participates within lysosomes in a thiol-disulfide interchange reaction converting cystine into cysteine and cysteine-cysteamine mixed disulfide, both of which can exit the lysosome in patients with cystinosis.
Status:
US Approved Rx
(2013)
Source:
NDA203389
(2013)
Source URL:
First approved in 1994
Source:
NDA020392
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Cysteamine (trade name CYSTAGON) is a cystine-depleting agent indicated for the treatment of corneal cystine crystal accumulation in patients with cystinosis. Cystinosis is an autosomal recessive inborn error of metabolism in which the transport of cystine out of lysosomes is abnormal; in the nephropathic form, accumulation of cystine and formation of crystals damage various organs, especially the kidney, leading to renal tubular Fanconi Syndrome and progressive glomerular failure, with end-stage renal failure by the end of the first decade of life. In four studies of cystinosis patients before cysteamine was available, renal death (need for transplant or dialysis) occurred at the median age of fewer than 10 years. Patients with cystinosis also experience growth failure, rickets, and photophobia due to cystine deposits in the cornea. With time most organs are damaged, including the retina, muscles and central nervous system. Cysteamine is an aminothiol that participates within lysosomes in a thiol-disulfide interchange reaction converting cystine into cysteine and cysteine-cysteamine mixed disulfide, both of which can exit the lysosome in patients with cystinosis.
Status:
US Approved Rx
(2009)
Source:
ANDA079070
(2009)
Source URL:
First approved in 1993
Source:
ACEON by SYMPLMED PHARMS LLC
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Perindoprilat is a metabolite of perindopril. Perindopril is a long-acting angiotensin converting enzyme (ACE) inhibitor and it is used to treat high blood pressure, heart failure or stable coronary artery disease. Perindopril is designed to allow oral administration as perindoprilat is poorly absorbed from the gastrointestinal tract.
Status:
US Approved Rx
(2009)
Source:
ANDA079070
(2009)
Source URL:
First approved in 1993
Source:
ACEON by SYMPLMED PHARMS LLC
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Conditions:
Perindoprilat is a metabolite of perindopril. Perindopril is a long-acting angiotensin converting enzyme (ACE) inhibitor and it is used to treat high blood pressure, heart failure or stable coronary artery disease. Perindopril is designed to allow oral administration as perindoprilat is poorly absorbed from the gastrointestinal tract.
Status:
US Approved Rx
(2009)
Source:
ANDA079070
(2009)
Source URL:
First approved in 1993
Source:
ACEON by SYMPLMED PHARMS LLC
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Perindoprilat is a metabolite of perindopril. Perindopril is a long-acting angiotensin converting enzyme (ACE) inhibitor and it is used to treat high blood pressure, heart failure or stable coronary artery disease. Perindopril is designed to allow oral administration as perindoprilat is poorly absorbed from the gastrointestinal tract.
Status:
US Approved Rx
(2009)
Source:
ANDA079070
(2009)
Source URL:
First approved in 1993
Source:
ACEON by SYMPLMED PHARMS LLC
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Perindoprilat is a metabolite of perindopril. Perindopril is a long-acting angiotensin converting enzyme (ACE) inhibitor and it is used to treat high blood pressure, heart failure or stable coronary artery disease. Perindopril is designed to allow oral administration as perindoprilat is poorly absorbed from the gastrointestinal tract.
Status:
US Approved Rx
(2009)
Source:
ANDA079070
(2009)
Source URL:
First approved in 1993
Source:
ACEON by SYMPLMED PHARMS LLC
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Perindoprilat is a metabolite of perindopril. Perindopril is a long-acting angiotensin converting enzyme (ACE) inhibitor and it is used to treat high blood pressure, heart failure or stable coronary artery disease. Perindopril is designed to allow oral administration as perindoprilat is poorly absorbed from the gastrointestinal tract.
Status:
US Approved Rx
(1993)
Source:
NDA020191
(1993)
Source URL:
First approved in 1993
Source:
NDA020191
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Lodoxamide is a mast-cell stabilizer for topical administration into the eye. This compound belongs to the class of organic compounds known as alpha amino acids and derivatives. Lodoxamide inhibits the in vivo Type I immediate hypersensitivity reaction. In vitro, Lodoxamide stabilizes mast cells and prevents antigen-stimulated release of histamine. In addition, Lodoxamide prevents the release of other mast cell inflammatory mediators and inhibits eosinophil chemotaxis. Although Lodoxamide's precise mechanism of action is unknown, the drug has been reported to prevent calcium influx into mast cells upon antigen stimulation. Among side effects to Lodoxamide, the most frequently reported ocular adverse experiences were transient burning, stinging, or discomfort upon instillation. Nonocular events reported were headache and heat sensation, dizziness, somnolence, nausea, stomach discomfort, sneezing, dry nose, and rash.
