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Search results for "ORPHAN DRUG" in comments (approximate match)
Status:
Designated
Source:
FDA ORPHAN DRUG:380012
Source URL:
Class:
NUCLEIC ACID
Status:
Designated
Source:
FDA ORPHAN DRUG:451914
Source URL:
Class:
NUCLEIC ACID
Status:
Designated
Source:
FDA ORPHAN DRUG:173903
Source URL:
Class:
NUCLEIC ACID
Status:
US Previously Marketed
Source:
TEGSEDI by AKCEA THERAPS
(2018)
Source URL:
First approved in 2018
Source:
TEGSEDI by AKCEA THERAPS
Source URL:
Class:
NUCLEIC ACID
Status:
US Previously Marketed
Source:
KYNAMRO by KASTLE THERAPS LLC
(2013)
Source URL:
First approved in 2013
Source:
KYNAMRO by KASTLE THERAPS LLC
Source URL:
Class:
NUCLEIC ACID
Status:
Possibly Marketed Outside US
First approved in 2007
Source:
21 CFR 352
Source URL:
Class:
NUCLEIC ACID
Status:
Possibly Marketed Outside US
Class:
NUCLEIC ACID
Status:
US Approved Rx
(2013)
Source:
NDA202207
(2013)
Source URL:
First approved in 2013
Source:
NDA202207
Source URL:
Class:
POLYMER
Targets:
Technetium (99mTc) tilmanocept, trade name Lymphoseek, is a radiopharmaceutical diagnostic imaging agent approved for the imaging of lymph nodes. It is used to locate those lymph nodes which may be draining from tumors, and assist doctors in locating those lymph nodes for removal during surgery.
Status:
US Approved Rx
(2012)
Source:
NDA202292
(2012)
Source URL:
First approved in 2012
Source:
NDA202292
Source URL:
Class:
POLYMER
Conditions:
Crofelemer, previously known as the investigational drug SP-303, is a novel proanthocyanidin purified from the bark latex of the Amazonian Croton tree Croton lechleri. It is marketed under the brand name Fulyzaq and indicated for the symptomatic treatment of non-infectious diarrhea in adult patients with HIV/AIDS who are taking antiretroviral therapy. Fulyzaq treats the symptoms of disease, but it is not used to treat infectious diarrhea (diarrhea caused by infection of the digestive system by a bacteria, virus or parasite). It was initially developed by Napo Pharmaceuticals, which licensed it to Glenmark Pharmaceuticals in 140 emerging markets and to Salix Pharmaceuticals in the US, EU and some other markets. A Phase III clinical trial for diarrhoea in HIV patients was completed in 2012, and the drug was approved by the US Food and Drug Administration (FDA) on 31 December 2012.
Status:
US Approved Rx
(1996)
Source:
NDA020193
(1996)
Source URL:
First approved in 1996
Source:
NDA020193
Source URL:
Class:
POLYMER
Conditions:
Pentosan polysulfate sodium (brand name ELMIRON) is a low molecular weight heparin-like compound. It has anticoagulant and fibrinolytic effects and is indicated for the relief of bladder pain or discomfort associated with interstitial cystitis. The mechanism of action of pentosan polysulfate sodium in interstitial cystitis is not known but was discovered, that it t binds Fibroblast growth factors (FGFs) as well as other heparin-binding growth factors.