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Status:
Possibly Marketed Outside US
Source:
NCT03237182: Phase 4 Interventional Terminated Tuberculosis, Multidrug-Resistant
(2017)
Source URL:
First approved in 2022
Source:
Kanamycin Sulfates by KDG Impresa LLC, Aqion
Source URL:
Class:
MIXTURE
Targets:
Kanamycin (a mixture of kanamycin A, B and C) is an aminoglycoside bacteriocidal antibiotic, available in oral, intravenous, and intramuscular forms, and used to treat a wide variety of infections. It is effective against Gram-negative bacteria and certain Gram-positive bacteria. Aminoglycosides work by binding to the bacterial 30S ribosomal subunit, causing misreading of t-RNA, leaving the bacterium unable to synthesize proteins vital to its growth. Serious side effects include tinnitus or loss of hearing, toxicity to kidneys, and allergic reactions to the drug. Mixing of an aminoglycoside with beta-lactam-type antibiotics (penicillins or cephalosporins) may result in a significant mutual inactivation. Even when an aminoglycoside and a penicillin-type drug are administered separately by different routes, a reduction in aminoglycoside serum half-life or serum levels has been reported in patients with impaired renal function and in some patients with normal renal function.
Status:
Possibly Marketed Outside US
Source:
NCT01284647: Phase 4 Interventional Completed Chronic Erosive Gastritis
(2011)
Source URL:
First approved in 2010
Source:
21 CFR 352
Source URL:
Class:
MIXTURE
Targets:
Conditions:
Tetraprenylacetone (Geranylgeranylacetone) is an anti-peptic ulcer drug developed and approved in Japan in 1984. Tetraprenylacetone is shown to suppress H. pylori induced tissue and cell injury and inflammatory reaction, so it is expected to show beneficial effects on H. pylori-infected tissues. Tetraprenylacetone is used to treat patients suffering from peptic ulcers and gastritis. In Japan it is sold under the brand name Selbex.
Status:
Possibly Marketed Outside US
Source:
Volu-Firm Day Cream Sunscreen Broad-Spectrum SPF 30
Source URL:
First approved in 2005
Source:
21 CFR 352
Source URL:
Class:
MIXTURE
Conditions:
Status:
Possibly Marketed Outside US
Source:
NU SKIN AGELOC ME
Source URL:
First approved in 2000
Source:
M016
Source URL:
Class:
MIXTURE
Conditions:
CERAMIDE NP (previously CERAMIDE 3) is a naturally occurring lipid and major component of the stratum corneum (outer skin layer). Levels of CERAMIDE NP decrease with advancing age. CERAMIDE NP is widely used as a moisturizer in cosmetic products because of its hydrating function. Interactions have been found with ceramide 1, synergistically improving the skin barrier function in humans, i.e. better skin hydration and less transepidermal water loss. There are no safety concerns for cosmetic products containing less than 1% CERAMIDE NP.
Status:
Possibly Marketed Outside US
Source:
Pain Relief Cream by ALLURE LABS INC.
Source URL:
First approved in 2000
Source:
Excel by United Pet Group
Source URL:
Class:
MIXTURE
Conditions:
Diazolidinylurea is a broad-spectrum antimicrobial preservative used in cosmetics and pharmaceutical preparations. It is especially active against gram-negative bacteria and is often combined with parabens. Diazolidinylurea is the most active member of the imidazolidinyl urea group, that acts as a formaldehyde releasers. Diazolidinylurea is used in many cosmetics, skin care products, shampoos, and conditioners, as well as a wide range of products including bubble baths, baby wipes, and household detergents.
Status:
Possibly Marketed Outside US
First approved in 1999
Source:
21 CFR 358H
Source URL:
Class:
MIXTURE
Conditions:
Cetrimide is a quaternary ammonium compound. Cetrimide was first introduced as a combined cleanser and skin antiseptic by Barnes (1942). Cetrimide combines excellent detergent properties and minimal toxicity with a useful antiseptic action. Cetrimide affects membrane permeability allowing ‘leaking’ of essential cell constituents leading to cell death. This medication is a skin antiseptic and disinfectant prescribed for seborrhoeic dermatitis and wound cleansing. The cream has a bactericidal activity against gram-positive bacteria and incompatible with soaps and other anionic surfactants.
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
Class:
MIXTURE
Targets:
Conditions:
Sulfomyxin is an antibacterial sulfonamide. It is intended for use in chickens and turkeys as an aid in the treatment of disease caused or complicated by E. coli, such as colibacillosis and complicated chronic respiratory disease.
Status:
US Approved Rx
(2022)
Source:
NDA022231
(2022)
Source URL:
First approved in 2022
Source:
NDA022231
Source URL:
Class:
PROTEIN
Terlipressin (Glypressin) is indicated for the treatment of bleeding oesophageal varices and in some countries for the treatment of hepatorenal syndrome type 1. It is a prodrug and is converted to the lysine vasopressin in the circulation after the N-triglycyl residue is cleaved by endothelial peptidases. This results in a ‘slow release’ of the vasoactive lysine vasopressin. Terlipressin exerts its action by activating V1a, V1b and V2 vasopressin receptors. On September 14, 2022, the FDA granted approval to terlipressin (Terlivaz) for the treatment of adults hospitalized with hepatorenal syndrome with rapid reduction in kidney function (HRS-1). Prior to the approval, no approved treatment for this condition existed in the United States.
Status:
US Approved Rx
(2022)
Source:
NDA022231
(2022)
Source URL:
First approved in 2022
Source:
NDA022231
Source URL:
Class:
PROTEIN
Terlipressin (Glypressin) is indicated for the treatment of bleeding oesophageal varices and in some countries for the treatment of hepatorenal syndrome type 1. It is a prodrug and is converted to the lysine vasopressin in the circulation after the N-triglycyl residue is cleaved by endothelial peptidases. This results in a ‘slow release’ of the vasoactive lysine vasopressin. Terlipressin exerts its action by activating V1a, V1b and V2 vasopressin receptors. On September 14, 2022, the FDA granted approval to terlipressin (Terlivaz) for the treatment of adults hospitalized with hepatorenal syndrome with rapid reduction in kidney function (HRS-1). Prior to the approval, no approved treatment for this condition existed in the United States.