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Search results for "ORPHAN DRUG|Designated/Withdrawn" in comments (approximate match)
Status:
Possibly Marketed Outside US
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Sulthiame is a potent inhibitor of carbonic anhydrase II, VII, IX, and XII. Sulthiame is an antiepileptic drug that is used widely in some European countries and in Israel. Sometimes it is used as an additional (add-on) antiepileptic medicine in non responders, alongside an existing antiepileptic medicine.
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
(2002)
Source:
BLA021484
(2002)
Source URL:
First approved in 1986
Source:
METRODIN by SERONO
Source URL:
Class:
MIXTURE
Status:
US Approved Rx
(1978)
First approved in 1978
Class:
MIXTURE
Status:
Investigational
Source:
NCT04562766: Phase 3 Interventional Active, not recruiting Immune Thrombocytopenia
(2020)
Source URL:
Class:
MIXTURE
Status:
Investigational
Source:
NCT00868166: Phase 3 Interventional Completed Amyotrophic Lateral Sclerosis
(2009)
Source URL:
Class:
MIXTURE
Status:
Investigational
Source:
NCT01900158: Phase 1 Interventional Completed Cholangiocarcinoma
(2013)
Source URL:
Class:
MIXTURE
Status:
Designated
Source:
FDA ORPHAN DRUG:516316
Source URL:
Class:
MIXTURE
Status:
Possibly Marketed Outside US
Source:
NCT00004317: Phase 4 Interventional Recruiting Toxoplasmosis
(2000)
Source URL:
Class:
MIXTURE
Targets:
Spiramycin, a macrolide antibiotic, has been studied in the United States for the treatment of cryptosporidial diarrhea. Some reports suggest that spiramycin is useful in improving the symptoms of cryptosporidial diarrhea in some patients. It has been used in Europe and Canada for over 20 years to treat bacterial infections. Serious adverse effects from spiramycin are apparently rare, and no drug-associated deaths have been reported. Spiramycin inhibits translocation by binding to bacterial 50S ribosomal subunits with an apparent 1:1 stoichiometry. This antibiotic is a potent inhibitor of the binding to the ribosome of both donor and acceptor substrates. Spiramycin induces rapid breakdown of polyribosomes, an effect which has formerly been interpreted as occurring by normal ribosomal run-off followed by an antibiotic-induced block at or shortly after initiation of a new peptide. However, there is now convincing evidence that spiramycin, and probably all macrolides, act primarily by stimulating the dissociation of peptidyl-tRNA from ribosomes during translocation
Status:
Possibly Marketed Outside US
Source:
Fiblaferon by Bioferon [W. Germany]
Source URL:
Class:
MIXTURE