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Status:
Possibly Marketed Outside US
Source:
21 CFR 333D
(2011)
Source URL:
First approved in 2011
Source:
21 CFR 333D
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Chrysin (aka 5,7-dihydroxyflavone) is a naturally occurring flavone found in honey, propolis, honeycomb, passion flowers, and Oroxylum indicum. Chrysin is used as an ingredient in dietary supplements and topical medications which are marketed to improve physical performance o treat various conditions. It has also been investigated for its immunoregulatory, anti-inflammatory an neuroprotective properties. Chrysin appears to be poorly absorbed and readily metabolize.
Status:
Possibly Marketed Outside US
Source:
21 CFR 352
(2011)
Source URL:
First approved in 2011
Source:
21 CFR 352
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Status:
Possibly Marketed Outside US
Source:
Stem Cell Renew by Medon Co., Ltd
(2011)
Source URL:
First approved in 2011
Source:
Stem Cell Renew by Medon Co., Ltd
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Pentigetide is a polar peptide derived from Immunoglobulin E (IgE) Fc region, with two acidic side chains, a basic side chain and free termini. It was developed to inhibit IgE-mediated allergic responses. A randomized, double-blind, placebo-controlled trial was conducted to evaluate the safety and efficacy of subcutaneously administered pentigetide in the treatment of allergic rhinitis. Mean symptom scores indicated that the frequency and severity of sneezing, rhinorrhea, and nasal itching decreased after 1 week of pentigetide treatment and remained decreased until study completion, whereas congestion was unchanged or slightly increased. In contrast, the frequency and severity of sneezing, rhinorrhea, and nasal itching increased after placebo treatment, with congestion essentially unchanged. No clinical or statistical differences in safety parameters between pentigetide and placebo treatments were observed. This double-blind, active-controlled trial demonstrates that pentigetide, 0.5%, ophthalmic solution is safe and effective in the treatment of allergic conjunctivitis. Pentigetide nasal solution was safe and effective for the treatment of seasonal allergic rhinitis.
Status:
Possibly Marketed Outside US
Source:
21 CFR 352
(2011)
Source URL:
First approved in 2011
Source:
21 CFR 352
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Ilomastat (also known as galardin or GM 6001) is a broad-spectrum matrix metalloproteinase inhibitor. It is a member of the hydroxamic acid class of reversible metallopeptidase inhibitors. The hydroxamic acid binds the catalytic zinc(2+) ion in a bidentate manner, blocking substrate access to the active site and rendering the metal incapable of peptide hydrolysis. Preclinical studies have shown that ilomastat can inhibit conjunctival scarring after glaucoma filtration surgery in rabbits, in lens capsules following simulated cataract surgery, and in models of vitreoretinal contraction.
Status:
Possibly Marketed Outside US
Source:
NADA141328
(2011)
Source URL:
First approved in 2011
Source:
NADA141328
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Gamithromycin, the active pharmaceutical ingredient of ZACTRAN is a novel 7a-azalide that has been developed for treatment and prevention of bovine respiratory disease (BRD). The compound belongs to the 15-membered semi-synthetic macrolide antibiotics of the azalide sub-class with a uniquely positioned alkylated nitrogen at the 7a-position of the lactone ring. Macrolide antibiotics in general have bacteriostatic action by inhibiting bacterial RNA dependent protein biosynthesis, but can also be bactericidal. They reversibly bind to 23S ribosomal RNA in the 50S-subunit of prokaryotic ribosomes and prevent protein elongation during the translocation process. In vitro data show that gamithromycin has both bactericidal and bacteriostatic actions at least at the higher concentrations found in lung tissue. The broad spectrum antimicrobial activity of gamithromycin includes Mannheimia haemolytica, Pasteurella multocida and Histophilus somni, the bacterial pathogens most commonly associated with BRD. Gamithromycin administered subcutaneously is well absorbed and fully bioavailable, and safe for the target animal receiving doses up to five times the recommended dose at 30 mg ⁄ kg body weight. Following s.c. administration, gamithromycin is extensively and rapidly distributed to lung tissue, the site of respiratory infection.
Status:
Possibly Marketed Outside US
Source:
21 CFR 352
(2011)
Source URL:
First approved in 2011
Source:
21 CFR 352
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Anisacril (or SKF 16046) was developed as an anti-obesity agent.
Status:
Possibly Marketed Outside US
First approved in 2011
Source:
EnBrace HR by Jaymac Pharma
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
DB00144 (1-propionyl-2-butyl phosphatidylserine) is a phosphatidylserine derivative. It consists of a propionic and butyric acid residues attached in ester linkage to the first and second carbon of glycerol and serine attached through a phosphodiester linkage to the third carbon of the glycerol. DB00144 is not found in natural sources of phosphatidylserine, which contain fatty acids with a length of 20-22 carbon atoms. DB00144 was detected as one of the cellular metabolites in murine myocardium.
Status:
Possibly Marketed Outside US
Source:
Garnier Ombrelle SPF 30 Sport Endurance Water Resistant by L'Oreal USA Products Inc
Source URL:
First approved in 2011
Source:
21 CFR 352
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Conditions:
Dometrizole trisiloxane (Mexoryl XL®) is a lipophilic benzotriazole derivative used in sunscreen products to absorb ultraviolet (UV). It is a broadspectrum UVB/UVA filter with two peaks of absorption: one at 303 nm and the other one at 344 nm. Sunscreens containing dometrizole trisiloxane (Mexoryl XL®) are important in impeding UVA light, potentially reducing many of the characteristics of skin aging and preventing biochemical changes that can lead to nonmelanoma carcinoma. It has not yet been approved in the US, but has been available worldwide for many years in different sunscreens made by L'Oreal.
Status:
Possibly Marketed Outside US
Source:
21 CFR 355
(2011)
Source URL:
First approved in 2011
Source:
21 CFR 355
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Status:
Possibly Marketed Outside US
Source:
Skinprint Recover Lightening Complex with 2% Hydroquinone by The Skin Atelier, Inc.
(2011)
Source URL:
First approved in 2011
Source:
Skinprint Recover Lightening Complex with 2% Hydroquinone by The Skin Atelier, Inc.
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)