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Status:
US Approved Rx
(2024)
Source:
ANDA219441
(2024)
Source URL:
First approved in 2008
Source:
NDA022212
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Difluprednate is a corticosteroid used as an anti-inflammatory steroidal drug used primarily in ocular surgery. It is thought to act by the induction of phospholipase A2 inhibitory proteins (lipocortins). It is postulated that these proteins control the biosynthesis of potent mediators of infammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2. It is marketed by Alcon under the tradename Durezol.
Status:
US Approved Rx
(2000)
Source:
NDA021077
(2000)
Source URL:
First approved in 1990
Source:
CUTIVATE by FOUGERA PHARMS
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Fluticasone propionate, a medium-potency synthetic corticosteroid, is used topically to relieve inflammatory and pruritic symptoms of dermatoses and psoriasis, intranasally to manage symptoms of allergic and non-allergic rhinitis, and orally for the treatment of asthma. Fluticasone proprionate is marketed under several different brand names such as Flonase®. Fluticasone propionate is also available as a combination product of azelastine hydrochloride and fluticasone propionate called Dymista™. Dymista™ is indicated in patients over 12 years old for symptomatic relief of seasonal allergic rhinitis. Fluticasone propionate binds to the glucocorticoid receptor. Unbound corticosteroids cross the membranes of cells such as mast cells and eosinophils, binding with high affinity to glucocorticoid receptors (GR). The results include alteration of transcription and protein synthesis, a decreased release of leukocytic acid hydrolases, reduction in fibroblast proliferation, prevention of macrophage accumulation at inflamed sites, reduction of collagen deposition, interference with leukocyte adhesion to the capillary wall, reduction of capillary membrane permeability and subsequent edema, reduction of complement components, inhibition of histamine and kinin release, and interference with the formation of scar tissue. In the management of asthma, the glucocorticoid receptor complexes down-regulates proinflammatory mediators such as interleukin-(IL)-1, 3, and 5, and up-regulates anti-inflammatory mediators such as IkappaB [inhibitory molecule for nuclear factor kappaB1], IL-10, and IL-12. The antiinflammatory actions of corticosteroids are also thought to involve inhibition of cytosolic phospholipase A2 (through activation of lipocortin-1 (annexin)) which controls the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes.
Status:
US Approved Rx
(1995)
Source:
ANDA074431
(1995)
Source URL:
First approved in 1986
Source:
OCUFEN by ALLERGAN
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Targets:
Flurbiprofen, a propionic acid derivative, is a nonsteroidal anti-inflammatory drug that exhibits antiinflammatory, analgesic, and antipyretic activities in animal models. Flurbiprofen Tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and for relief of the signs and symptoms of osteoarthritis. It may also be used to treat pain associated with dysmenorrhea and mild to moderate pain accompanied by inflammation (e.g. bursitis, tendonitis, soft tissue trauma). Flurbiprofen may also be used topically prior to ocular surgery to prevent or reduce intraoperative miosis. Similar to other NSAIAs, the anti-inflammatory effect of flurbiprofen occurs via reversible inhibition of cyclooxygenase (COX), the enzyme responsible for the conversion of arachidonic acid to prostaglandin G2 (PGG2) and PGG2 to prostaglandin H2 (PGH2) in the prostaglandin synthesis pathway. This effectively decreases the concentration of prostaglandins involved in inflammation, pain, swelling and fever. Flurbiprofen is a non-selective COX inhibitor and inhibits the activity of both COX-1 and -2. It is also one of the most potent NSAIAs in terms of prostaglandin inhibitory activity.
Status:
US Approved Rx
(2017)
Source:
ANDA206136
(2017)
Source URL:
First approved in 1982
Source:
NDA018147
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Piroxicam is in a class of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). It was originally brought to market by Pfizer under the tradename Feldene in 1980, became generic in 1992, and is marketed worldwide under many brandnames. Piroxicam works by reducing hormones that cause inflammation and pain in the body. Piroxicam is used to reduce the pain, inflammation, and stiffness caused by rheumatoid arthritis and osteoarthritis. The antiinflammatory effect of Piroxicam may result from the reversible inhibition of cyclooxygenase, causing the peripheral inhibition of prostaglandin synthesis. The prostaglandins are produced by an enzyme called Cox-1. Piroxicam blocks the Cox-1 enzyme, resulting into the disruption of production of prostaglandins. Piroxicam also inhibits the migration of leukocytes into sites of inflammation and prevents the formation of thromboxane A2, an aggregating agent, by the platelets. Piroxicam is used for treatment of osteoarthritis and rheumatoid arthritis.
Status:
US Approved Rx
(1986)
Source:
ANDA071081
(1986)
Source URL:
First approved in 1980
Source:
MECLOMEN by PARKE DAVIS
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Meclofenamic acid, used as Meclofenamate sodium, is a non-steroidal anti-inflammatory agent with antipyretic and antigranulation activities. Meclofenamate sodium capsules are indicated for the relief of mild to moderate pain, for the treatment of primary dysmenorrhea and for the treatment of idiopathic heavy menstrual blood loss; for relief of signs and symptoms of juvenile arthritis; so as for relief of the signs and symptoms of rheumatoid arthritis; For relief of the signs and symptoms of osteoarthritis. The mode of action, like that of other nonsteroidal anti-inflammatory agents, is not known. Therapeutic action does not result from pituitary-adrenal stimulation. In animal studies, meclofenamate sodium was found to inhibit prostaglandin synthesis and to compete for binding at the prostaglandin receptor site. In vitro, meclofenamate sodium was found to be an inhibitor of human leukocyte 5-lipoxygenase activity. These properties may be responsible for the anti-inflammatory action of meclofenamate sodium. There is no evidence that meclofenamate sodium alters the course of the underlying disease.
Status:
US Approved Rx
(1991)
Source:
ANDA072711
(1991)
Source URL:
First approved in 1978
Source:
CLINORIL by MERCK
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Targets:
Sulindac is a nonsteroidal anti-inflammatory agent (NSAIA) of the arylalkanoic acid class that is marketed in the U.S. by Merck as Clinoril. Like other NSAIAs, it may be used in the treatment of acute or chronic inflammatory conditions. Sulindac is a prodrug, derived from sulfinylindene, that is converted in vivo to an active sulfide compound by liver enzymes. The sulfide metabolite then undergoes enterohepatic circulation; it is excreted in the bile and then reabsorbed from the intestine. This is thought to help maintain constant blood levels with reduced gastrointestinal side effects. Some studies have shown sulindac to be relatively less irritating to the stomach than other NSAIA's except for drugs of the cyclooxygenase-2 (COX-2) inhibitor class. The exact mechanism of its NSAIA properties is unknown, but it is thought to act on enzymes COX-1 and COX-2, inhibiting prostaglandin synthesis.
Status:
US Approved Rx
(2021)
Source:
ANDA214723
(2021)
Source URL:
First approved in 1974
Source:
NDA017556
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Halcinonide is one of the available highly potent topical cor¬ticosteroids. It is a derivative of hydrocortisone and contains important modifications in its structure that alter its absorption, potency, and adverse effects compared with hydrocortisone. Halcinonide—along with desoximetasone, betamethasone, fluocinonide, and diflorasone diacetate—is classified as a Class II potency corticosteroid. Although similar in strength, halcinonide in Halog (the only topical product available that contains halcinonide) differs from many other compounds of this class in the formulation. Halcinonide cream is formulated in a biphasic base that allows for immediate-release of halcinonide upon application to the skin, followed by a delayed and sustained release of halcinonide over time. This “dual formulation” strategy allows for prolonged halcinonide activity. The formulation of halcinonide cream contains microcrystals of halcinonide. An equilibrium is established between dissolved halcinonide in the cream and non-dissolved halcinonide in the microcrystals. As soluble hal¬cinonide enters the skin, additional quantities of halcinonide from the microcrystals become available as a new equilibrium is established. This dynamic equilibrium serves to maintain a sustained level of halcinonide well beyond the time of application.
Status:
US Approved Rx
(1992)
Source:
ANDA073548
(1992)
Source URL:
First approved in 1972
Source:
NDA017010
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Desonide is a topical glucocorticoid which was approved by FDA for the treatment of such conditions as eczema, psoriasis, atopic dermatitis, etc. The exact mechanism of drug action is unknown.
Status:
US Approved Rx
(2010)
Source:
ANDA091396
(2010)
Source URL:
First approved in 1955
Source:
DELTA-CORTEF by PHARMACIA AND UPJOHN
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Prednisolone hemisuccinate is a prodrug of a glucocorticoid agonist prednisolone, which is marketed under trade name Prednisolut in Germany and Austria. Prednisolone hemisuccinate is used in emergency medicine to treate shock due to allergic reaction, insect and snake bites, in neurology to treat brain edema and meningitis, in transplantation medicine to reduce risk of organ refection after kidney transplane, in pneumology to treat acute asthma attack, pulmonary edema, in severe or life-threatening situation in rheumatic diseases.
Class (Stereo):
CHEMICAL (ABSOLUTE)
Drocinonide is a synthetic glucocorticoid used as anti-inflammatory agent. It was shown that drocinonide phosphate potassium is effective ocular anti-inflammatory agent that does not show a strong tendency to elevate the intra-ocular pressure. Drocinonide phosphate potassium forms an insoluble complex with neomycin sulfate in aqueous solution. Dibasic sodium phosphate can be employed in an ophthalmic formulation to prevent the formation of this precipitate without affecting the stability of the steroid or the bioactivity of the antibiotic.