Isotretinoin, also known as 13-cis-retinoic acid, is a medication primarily used to treat severe acne. Rarely, it is also used to prevent certain skin cancers, and in the treatment of other cancers. It is used to treat harlequin-type ichthyosis, a usually lethal skin disease, and lamellar ichthyosis. It is a retinoid, meaning it is related to vitamin A, and is found in small quantities naturally in the body. Its isomer, tretinoin, is also an acne drug.
A new chemical entity (NCE) is, according to the U.S. Food and Drug Administration, a drug that contains no active moiety that has been approved by the FDA in any other application submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act.
Clinical research is a branch of healthcare science that determines the safety and effectiveness (efficacy) of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. Clinical research is different from clinical practice. In clinical practice established treatments are used, while in clinical research evidence is collected to establish a treatment.
Rintatolimod, sold under the tradename Ampligen, is a medication intended for treatment of chronic fatigue syndrome (CFS). There is low-strength evidence it can diminish CFS symptoms.
The Oncologic Drugs Advisory Committee (ODAC) receives requests for technical and clinical evaluation of new drugs by the U.S. Food and Drug Administration (FDA). The committee, consisting of members from academic and clinical oncology biostatistics, the general public, and the pharmaceutical industry, makes non-binding recommendations to both the CDER and CBER divisions of the FDA about the advisability of approving new medications to treat cancer.
A biosimilar is a biologic medical product that is almost an identical copy of an original product that is manufactured by a different company. Biosimilars are officially approved versions of original "innovator" products and can be manufactured when the original product's patent expires. Reference to the innovator product is an integral component of the approval.
{{Drugbox | Verifiedfields = changed | Watchedfields = changed | verifiedrevid = 385028149 | IUPAC_name = 2-deoxy-1-O-[(3S,15R,18R,34R,35S,38S,48R,50aR)-5,31-dichloro-38-{[3-(dimethylamino)propyl]carbamoyl}-6,11,34,40,44-pentahydroxy-42-(α-D-mannopyranosyloxy)-15-(methylamino)-2,16,36,50,51,59-hexaoxo-2,3,16,17,18,19,35,36,37,38,48,49,50,50a-tetradecahydro-1H,15H,34H-20,23:30,33-dietheno-3,18:35,48-bis(iminomethano) 4,8:10,14:25,28:43,47-tetrametheno[1,14,6,22]dioxadiazacyclooctacosino[4,5-m][10,2,16]benzoxadiazacyclotetracosin-56-yl]-2-[(10-methylundecanoyl)amino]-β-D-glucopyranuronic acid | image = Dalbavancin_B0.svg | tradename = Dalvance, Xydalba | pregnancy_AU = | pregnancy_US = | pregnancy_category = | licence_EU = yes | legal_AU = | legal_CA = | legal_UK = | legal_US = | legal_status = | routes_of_administration = Intravenous | bioavailability = | protein_bound = | metabolism = | elimination_half-life = | excretion = | CAS_number_Ref = | CAS_number = 171500-79-1 | ATC_prefix = J01 | ATC_suffix = XA04 | PubChem = 16134410 | DrugBank_Ref = | DrugBank = | UNII_Ref = | UNII = 808UI9MS5K | ChEBI_Ref = | ChEBI = 82721 | ChEMBL_Ref = | ChEMBL = 527063 | ChemSpiderID_Ref = | ChemSpiderID = 23340937 | smiles = CC(C)CCCCCCCCC(=O)N[C@@H]1[C@H]([C@@H] O)O | StdInChI_Ref = | StdInChI = 1S/C88H100Cl2N10O28/c1-38(2)13-10-8-6-7-9-11-14-61(106)94-70-73(109)75(111)78(86 121)128-87(70)127-77-58-31-43-32-59(77)124-55-23-19-42(29-50 89)71(107)69-85(119)98-67(80 92-25-12-26-100 5)48-33-44(102)34-57(125-88-76 74 72 60 126-88)62(48)47-28-40(17-22-52 103)65(82 99-69)95-83(117)66(43)96-84(118)68-49-35-46(36-54 63 90)123-56-24-18-41(30-53 104)64(91-3)81(115)93-51(79 97-68)27-39-15-20-45(122-58)21-16-39/h15-24,28-36,38,51,60,64-76,78,87-88,91,101-105,107-112H,6-14,25-27,37H2,1-5H3,(H,92,114)(H,93,115)(H,94,106)(H,95,117)(H,96,118)(H,97,113)(H,98,119)(H,99,116)(H,120,121)/t51-,60-,64-,65-,66-,67+,68+,69+,70-,71-,72-,73-,74+,75+,76+,78+,87-,88+/m1/s1 | StdInChIKey_Ref = | StdInChIKey = IZJRUXNZMRDQJI-SZUNQUCBSA-N | C=88 | H=100 | Cl=2 | N=10 | O=28 | molecular_weight = 1816.7 g/mol }}
President of the United States George W. Bush signed the Food and Drug Administration Amendments Act of 2007 (FDAAA) on September 27, 2007. This law reviewed, expanded, and reaffirmed several existing pieces of legislation regulating the FDA. These changes allow the FDA to perform more comprehensive reviews of potential new drugs and devices. It was sponsored by Reps. Joe Barton and Frank Pallone and passed unanimously by the Senate.
Vernakalant is an investigational drug under regulatory review for the acute conversion of atrial fibrillation. It was initially developed by Cardiome Pharma, and the intravenous formulation was bought for further development by Merck in April 2009. In September 2012, Merck terminated its agreements with Cardiome and has consequently returned all rights of the drug back to Cardiome.
Tanezumab is a monoclonal antibody against nerve growth factor as a treatment for pain. Tanezumab was discovered and developed by Rinat Neuroscience and was acquired by Pfizer in 2006.
Gadoteric acid (gadoterate meglumine, trade names Artirem, Dotarem and Clariscan) is a macrocycle-structured gadolinium-based MRI contrast agent (GBCA). It consists of the organic acid DOTA as a chelating agent, and gadolinium (Gd3+), and is used in form of the meglumine salt (Gadoterate meglumine). The paramagnetic property of gadoteric acid reduces the T1 relaxation time (and to some extent the T2 and T2* relaxation times) in MRI, which is the source of its clinical utility. Because it has magnetic properties, gadoteric acid develops a magnetic moment when put under a magnetic field, which increases the signal intensity (brightness) of tissues during MRI imaging.
ClinicalTrials.gov is a registry of clinical trials. It is run by the United States National Library of Medicine (NLM) at the National Institutes of Health, and is the largest clinical trials database, currently holding registrations from over 230,000 trials from 195 countries in the world.
EpiCeram is a topical non-steroidal skin cream. Based on the research of Peter M. Elias it is made up of ceramides, free fatty acids and cholesterol, and is designed to treat atopic dermatitis, a type of eczema. Ceragenix obtained marketing clearance from the U.S. Food and Drug Administration in April 2006. This prescription medical device works as a moisturizer and barrier cream. In the US, it requires prescription and was launched in October 2008 by Promius Pharma. EpiCeram was acquired by PuraCap Pharmaceutical LLC in 2010.
The Skin Cancer Foundation (SCF), founded in 1979 by dermatologist and Mohs surgeon Perry Robins, MD, is a global organization solely devoted to educating the public and medical community about skin cancer prevention, early detection, and treatment. The foundation's professional membership includes dermatologists, Mohs surgeons, plastic surgeons and other medical professionals working to fight skin cancer. Headquartered in New York City, the foundation is a 501(c)(3) public charity.
Mapracorat is an anti-inflammatory drug belonging to the experimental class of selective glucocorticoid receptor agonists (SEGRAs). It is in clinical trials for the topical treatment of atopic dermatitis, inflammation following cataract surgery, and allergic conjunctivitis. Preliminary investigation for the treatment of keratoconjunctivitis sicca has been conducted in cellular models.
Alcaftadine is used to prevent eye irritation brought on by allergic conjunctivitis. It is a H1 histamine receptor antagonist.
Teprotumumab (RG-1507) is an experimental human monoclonal antibody developed by Genmab and Roche. It binds to IGF-1R.
Bezlotoxumab is a human monoclonal antibody designed for the prevention of recurrence of Clostridium difficile infections.
Ceftazidime/avibactam is a combination drug composed of ceftazidime, a cephalosporin antibiotic, and avibactam, a β-lactamase inhibitor. It is used for the treatment of serious bacterial infections.
