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Status:
US Previously Marketed
First marketed in 1919
Class:
MIXTURE
Targets:
Conditions:
Acriflavine (ACF) is a topical antiseptic. The hydrochloride form is more irritating than the neutral form. It is derived from acridine. Commercial preparations are often mixtures with proflavine. Acriflavine was developed in 1912 by Paul Ehrlich, a German medical researcher, and was used during the First World War against sleeping sickness. ACF has known trypanocidal, antibacterial, and antiviral activities. Effects of ACF on cancer cells were first reported 50 years ago. By present time was demonstrated that ACF a drug, that binds directly to HIF-1 alpha and HIF-2 alpha and inhibits HIF-1 dimerization and transcriptional activity and thus has potent inhibitory effects on tumor growth and vascularization. Also Acriflavine in combination with 3,6-diaminoacridine (proflavine) could prove to be a potential antimalarial drug and its pharmacological action can be due to inhibition of gyrase activity. This is achieved through interaction of the ACF with the DNA substrate. This interaction may lead to conformation change in DNA unsuitable for binding of gyrase with DNA.
Status:
Possibly Marketed Outside US
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:
US Approved Rx
(2004)
Source:
NDA021256
(2004)
Source URL:
First approved in 2004
Source:
NDA021256
Source URL:
Class:
PROTEIN
Targets:
Conditions:
Human secretin is a gastrointestinal peptide hormone that regulates secretions in the stomach, pancreas, and liver. Synthetic human secretin displays equivalent biological activity and properties as naturally occurring secretin. Acetate salt of synthetic secretin was marketed under the name ChiRhoStim. ChiRhoStim is indicated for the stimulation of pancreatic secretions, including bicarbonate, to aid in the diagnosis of pancreatic exocrine dysfunction, for the gastrin secretion to aid in the diagnosis of gastrinoma. ChiRhoStim is also used for the pancreatic secretions to facilitate the identification of the ampulla of Vater and accessory papilla during endoscopic, retrograde cholangiopancreatography (ERCP). When secretin binds to secretin receptors on pancreatic duct cells it opens cystic fibrosis transmembrane conductance regulator (CFTR) channels, leading to secretion of bicarbonate-rich-pancreatic fluid.
Status:
US Approved Rx
(2004)
Source:
NDA021256
(2004)
Source URL:
First approved in 2004
Source:
NDA021256
Source URL:
Class:
PROTEIN
Targets:
Conditions:
Human secretin is a gastrointestinal peptide hormone that regulates secretions in the stomach, pancreas, and liver. Synthetic human secretin displays equivalent biological activity and properties as naturally occurring secretin. Acetate salt of synthetic secretin was marketed under the name ChiRhoStim. ChiRhoStim is indicated for the stimulation of pancreatic secretions, including bicarbonate, to aid in the diagnosis of pancreatic exocrine dysfunction, for the gastrin secretion to aid in the diagnosis of gastrinoma. ChiRhoStim is also used for the pancreatic secretions to facilitate the identification of the ampulla of Vater and accessory papilla during endoscopic, retrograde cholangiopancreatography (ERCP). When secretin binds to secretin receptors on pancreatic duct cells it opens cystic fibrosis transmembrane conductance regulator (CFTR) channels, leading to secretion of bicarbonate-rich-pancreatic fluid.
Status:
US Approved Rx
(1996)
Source:
BLA020162
(1996)
Source URL:
First approved in 1996
Source:
BLA020162
Source URL:
Class:
PROTEIN
Conditions:
Corticorelin ovine is an analogue of the naturally occurring human corticotropin-releasing hormone (hCRH) peptide. Corticorelin ovine is a potent stimulator of adrenocorticotropic hormone (ACTH) release from the anterior pituitary. ACTH stimulates cortisol production from the adrenal cortex. Corticorelin ovine was marketed under the brand name ACTHREL for use in differentiating pituitary and ectopic production of ACTH in patients with ACTH-dependent Cushing’s syndrome.
Status:
US Approved Rx
(2023)
Source:
ANDA211097
(2023)
Source URL:
First approved in 1987
Source:
PARATHAR by SANOFI AVENTIS US
Source URL:
Class:
PROTEIN
Conditions:
Teriparatide was manufactured under the brand name FORTEO. FORTEO contains recombinant human parathyroid hormone (1-34), [rhPTH(1-34)], which has an identical sequence to the 34 N-terminal amino acids (the biologically active region) of the 84-amino acid human parathyroid hormone, that regulates calcium and phosphate in the body. FORTEO is indicated for the treatment of postmenopausal women with severe osteoporosis who are at high risk of fracture or who have failed or are intolerant to previous osteoporosis therapy. In addition, Forteo is used for the treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in men and women who are at increased risk for fracture. The biological actions of teriparatide is mediated through binding to specific high-affinity cell-surface receptors. Teriparatide is not expected to accumulate in bone or other tissues.
Status:
US Approved Rx
(2020)
Source:
NDA209376
(2020)
Source URL:
First marketed in 1921
Source:
Copper Sulphate U.S.P.
Source URL:
Class:
PROTEIN
Targets:
Conditions:
Tetraamminecopper dihydroxide also known as Schweizer's Reagent dissolves cellulose; used in rayon production.
Status:
US Approved OTC
Source:
21 CFR 347.10(t) skin protectant zinc carbonate
Source URL:
First marketed in 1921
Source:
Precipitated Zinc Carbonate U.S.P.
Source URL:
Class:
PROTEIN
Targets:
Conditions:
Zinc monocarbonate (Zinc Carbonate) is an inorganic salt. In the United States, Zinc Carbonate may be used as an active ingredient in OTC drug products. When used as an active drug ingredient, the established name is Zinc Carbonate. Zinc monocarbonate is generally recognized as safe by FDA. It is used as skin protectant active ingredient. Zinc carbonate was found to retard the degradation of some poly(lactide-co-glycolide) (PLG) microspheres in vivo and in vitro. Adding Zinc Carbonate is essential during the preparation of PLGA microspheres. It can remarkably improve the stability of drugs in the acid microenvironment inside PLGA microspheres.
Status:
US Previously Marketed
Source:
NATRECOR by SCIOS LLC
(2001)
Source URL:
First approved in 2001
Source:
NDA020920
Source URL:
Class:
PROTEIN
Conditions:
Nesiritide is the recombinant form of the 32 amino acid human B-type natriuretic peptide (BNP), which is normally produced by the ventricular myocardium. Human BNP binds to the particulate guanylate cyclase receptor of vascular smooth muscle and endothelial cells, leading to increased intracellular concentrations of guanosine 3'5'-cyclic monophosphate (cGMP) and smooth muscle cell relaxation. Cyclic GMP serves as a second messenger to dilate veins and arteries. Nesiritid was sold under brand name Natrecor for the intravenous treatment of patients with acutely decompensated congestive heart failure who have dyspnea at rest or with minimal activity.
Status:
US Approved Rx
(2013)
Source:
NDA205098
(2013)
Source URL:
First approved in 2010
Source:
NDA021201
Source URL:
Class:
POLYMER
Targets:
Conditions:
Polidocanol is a non-ionic surfactant sclerosing agent indicated to treat uncomplicated spider veins and uncomplicated reticular veins in the lower extremity. Polidocanol also is indicated for the treatment of incompetent great saphenous veins, accessory saphenous veins, and visible varicosities of the great saphenous vein system above and below the knee. When administered, polidocanol locally damages blood vessel endothelium. Following the endothelial damage, platelets aggregate at the site and attach to the venous wall eventually resulting in a dense network of platelets, cellular debris, and fibrin that occludes the vessel. Eventually the vessel is replaced by connective fibrous tissue. Adverse reactions include pain in extremity, infusion site thrombosis, contusion/injection site hematoma, limb discomfort and some others.