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Status:
Other
Class (Stereo):
CHEMICAL (ACHIRAL)
Chelidonic acid (CA) is a γ-pyrone which is contained in the rhizome of Chelidonium majus L. It has multiple pharmacological effects including those of a mild analgesic, an antimicrobial, an oncostatic, a central nervous system sedative and the anti-inflammatory effect. Chelidonic acid evokes antidepressant-like effect through the up-regulation of BDNF in forced swimming test. Chelidonic acid administration significantly increased the mRNA expression of hippocampal estrogen receptor-β. The levels of hippocampal interleukin (IL)-1β, IL-6, and tumor necrosis factor-α were effectively attenuated by the administration of chelidonic acid. In addition, chelidonic acid significantly increased the levels of 5-hydroxytryptamine (serotonin), dopamine, and norepinephrine compared with those levels for the mice that were administered distilled water in the hippocampus. Chelidonic acid might serve as a new therapeutic strategy for the regulation of depression associated with inflammation.
Status:
Other
Class (Stereo):
CHEMICAL (ABSOLUTE)
Gingerol (6-Gingerol) is bioactive compound found in ginger (Zingiber officinale) with antioxidant activity, which functions as an anti-inflammatory and antitumor agent. 6-Gingerol has been found to possess anticancer activities via its effect on a variety of biological pathways involved in apoptosis, cell cycle regulation, cytotoxic activity, and inhibition of angiogenesis. Gingerol has been investigated for its effect on cancerous tumors in the bowel, breast tissue, ovaries, the pancreas, among other tissues, with positive results. In phase II clinical trials Gingerol was successfully studied for preventing chemotherapy- induced nausea and vomiting in patients receiving highly emetogenic chemotherapy.
Status:
US Previously Marketed
Source:
BEXTRA by GD SEARLE
(2001)
Source URL:
First approved in 2001
Source:
BEXTRA by GD SEARLE
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Valdecoxib, a selective cyclooxygenase-2 (COX-2) inhibitor, is classified as a nonsteroidal anti-inflammatory drug (NSAID). Valdecoxib was manufactured and marketed under the brand name Bextra. Bextra was indicated for relief of the signs and symptoms of osteoarthritis and adult rheumatoid arthritis. For the treatment of primary dysmenorrhea. But in 2005 FDA requested that Pfizer withdraw Bextra from the American market, because the Agency had concluded that the overall risk versus benefit profile of Bextra was unfavorable. That conclusion was based on the potential increased risk for serious cardiovascular (CV) adverse events, an increased risk of serious skin reactions (e.g., toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme) compared to other NSAIDs, and the fact that Bextra had not been shown to offer any unique advantages over the other available NSAIDs.
Status:
US Previously Marketed
Source:
VIOXX by MERCK
(2004)
Source URL:
First approved in 1999
Source:
VIOXX by MERCK
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Rofecoxib is a nonsteroidal anti-inflammatory drug which selectively inhibits COX-2 and subsequent prostaglandin synthesis. The drug was developed by Merk and approved by FDA in 1999 for relief of signs and symptoms of arthritis, acute pain in adults, and painful menstrual cycles under the name Vioxx. Later on Merck voluntarily withdrawn Vioxx from the market due to safety concerns (high risk of heart attack and stroke).
Status:
US Previously Marketed
Source:
RIMADYL by ROCHE
(1987)
Source URL:
First approved in 1987
Source:
RIMADYL by ROCHE
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Targets:
Conditions:
Carprofen is an anti-inflammatory drug developed in Japan by Nippon Roche Research Center. Carprofen, as many NSAIDs, selectively inhibits COX-2 and was shown to suppress inflammation in vitro, using osteoarthritis models. The drug was approved by FDA for human use under the name Ridamyl, however, now it is sold only for veterinary purposes and prescribed for the treatment of postoperative pain and the relief of pain and inflammation associated with osteoarthritis in dogs.
Status:
US Previously Marketed
Source:
21 CFR 310.545(a)(18)(v)(B) skin protectant:insect bites/stings w/ sales less than $25,000 glyceryl stearate
Source URL:
First approved in 1971
Source:
ANDA090256
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Conditions:
Glyceryl 1-stearate (Glycerol monostearate), commonly known as GMS, is an organic molecule used as an emulsifier. GMS is a white, odorless, and sweet-tasting flaky powder that is hygroscopic. It is a glycerol ester of stearicacid. It occurs naturally in the body as a product of the breakdown of fats by pancreatic lipase, and is also found in fatty foods. GMS is a food additive used as a thickening, emulsifying, anti-caking, and preservative agent; an emulsifying agent for oils, waxes, and solvents; a protective coating for hygroscopic powders; a solidifier and control release agent in pharmaceuticals; and a resin lubricant. It is also used in cosmetics and hair care products. Used in antiperspirants and deodorants, baby care, body care, facial care, sun care, conditioners, facial make-up, creams and lotions-skin care, sprayable emulsions, feet, hands and nails, self-tanning, nail grooming and color cosmetics. GMS is largely used in baking preparations to add "body" to the food. It is responsible for giving ice cream and whipped cream its smooth texture. It is sometimes used as an anti-staling agent in bread. Glycerol 1-stearate is affirmed by FDA as GRAS.
Status:
First approved in 1958
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Diethylamine salicylate is a salicylic acid salt, that is a cost-effective and simple, first-line treatment for rheumatic and minor musculoskeletal conditions including lumbago, fibrositis, sciatica, bruises, and strains. Salicylic acid directly and irreversibly inhibits the activity of both types of cyclo-oxygenases (COX-1 and COX-2) to decrease the formation of precursors of prostaglandins and thromboxanes from arachidonic acid. Salicylate's antirheumatic (nonsteroidal anti-inflammatory) actions are a result of its analgesic and anti-inflammatory mechanisms.
Status:
US Previously Marketed
Source:
Acetphenetidin U.S.P.
(1921)
Source URL:
First marketed in 1887
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Phenacetin was used as an analgesic and fever-reducing drug in both human and veterinary medicine for many years. Since a major portion of a dose of phenacetin is rapidly metabolised to paracetamol, it seems possible that phenacetin owes some of its therapeutic activity to its main metabolite, paracetamol, whereas its most troublesome side effect (methaemoglobinaemia) is due to another metabolite, p-phenetidine.
Phenacetin was shown to inhibit cyclooxygenase (COX)-3, a cyclooxygenase-1 variant while p-phenetidine potently inhibits both COX-1 and COX-2. There is sufficient evidence in humans for the carcinogenicity of analgesic mixtures containing phenacetin. Analgesic mixtures containing phenacetin cause cancer of the renal pelvis, and of the ureter. Phenacetin was withdrawn from many analgesic mixtures long before the legal ban in several countries.