New Zealand - English - Medsafe (Medicines Safety Authority)

leo pharma limited - azelaic acid 20% - topical cream - 20 % - active: azelaic acid 20% excipient: benzoic acid cetearyl octanoate glycerol cutina cbs polyethylene glycol 200 monostearate propylene glycol purified water - topical treatment of acne vulgaris.

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

leo pharma a.s. - azelaic acid 20 g - cream - 20 % - azelaic acid 200 mg/g - azelaic acid

United States - English - NLM (National Library of Medicine)

bayer healthcare pharmaceuticals inc. - azelaic acid (unii: f2vw3d43yt) (azelaic acid - unii:f2vw3d43yt) - azelaic acid 0.15 g in 1 g - finacea® (azelaic acid) gel, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. although some reduction of erythema which was present in patients with papules and pustules of rosacea occurred in clinical studies, efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated. none. there are no adequate and well-controlled studies in pregnant women. therefore, finacea gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. dermal embryofetal developmental toxicology studies have not been performed with azelaic acid, 15% gel. oral embryofetal developmental studies were conducted with azelaic acid in rats, rabbits, and cynomolgus monkeys. azelaic acid was administered during the period of organogenesis in all three animal species. embryotoxicity was observed in rats, rabbits, and monkeys at oral doses of azelaic acid that generated some maternal toxicity. e

United States - English - NLM (National Library of Medicine)

alvogen, inc. - azelaic acid (unii: f2vw3d43yt) (azelaic acid - unii:f2vw3d43yt) - azelaic acid 0.15 g in 1 g

United States - English - NLM (National Library of Medicine)

bayer healthcare pharmaceuticals inc. - azelaic acid (unii: f2vw3d43yt) (azelaic acid - unii:f2vw3d43yt) - azelaic acid .15 g in 1 g - finacea(azelaic acid) foam, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. none. there are no adequate and well-controlled studies in pregnant women. therefore, finacea foam should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. dermal embryofetal developmental toxicology studies have not been performed with azelaic acid, 15% foam. oral embryofetal developmental studies were conducted with azelaic acid in rats, rabbits, and cynomolgus monkeys. azelaic acid was administered during the period of organogenesis in all three animal species. embryotoxicity was observed in rats, rabbits, and monkeys at oral doses of azelaic acid that generated some maternal toxicity. embryotoxicity was observed in rats given 2500 mg/kg/day [162 times the maximum recommended human dose (mrhd) based on body surface area (bsa)], rabbits given 150 or 500 mg/kg/day (19 or 65 times the mrhd based on bsa) and cynomolgus monkeys g

United States - English - NLM (National Library of Medicine)

amneal pharmaceuticals of new york llc - azelaic acid (unii: f2vw3d43yt) (azelaic acid - unii:f2vw3d43yt) - azelaic acid gel, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. limitations of use although some reduction of erythema which was present in patients with papules and pustules of rosacea occurred in clinical studies, efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated. none. risk summary azelaic acid is minimally absorbed systemically following topical route of administration, and maternal use is not expected to result in fetal exposure to the drug [see clinical pharmacology ( 12.3)]. in animal reproduction studies, embryofetal toxicity was noted when azelaic acid was administered orally during the period of organogenesis at doses 162, 19, and 65 times the maximum recommended human dose (mrhd) in rats, rabbits, and monkeys, respectively. maternal toxicity was noted at these doses but no malformations were observed in these embryofetal developmental studies (see data) . the background ris

United States - English - NLM (National Library of Medicine)

actavis pharma, inc. - azelaic acid (unii: f2vw3d43yt) (azelaic acid - unii:f2vw3d43yt) - azelaic acid gel, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. limitations of use although some reduction of erythema which was present in patients with papules and pustules of rosacea occurred in clinical studies, efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated. none.  risk summary azelaic acid is minimally absorbed systemically following topical route of administration, and maternal use is not expected to result in fetal exposure to the drug [see clinical pharmacology (12.3)]. in animal reproduction studies, embryofetal toxicity was noted when azelaic acid was administered orally during the period of organogenesis at doses 162, 19, and 65 times the maximum recommended human dose (mrhd) in rats, rabbits, and monkeys, respectively. maternal toxicity was noted at these doses but no malformations were observed in these embryofetal developmental studies (see data) . the background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data animal data dermal embryofetal developmental toxicology studies have not been performed with azelaic acid, 15% gel. oral embryofetal developmental studies were conducted with azelaic acid in rats, rabbits, and cynomolgus monkeys. azelaic acid was administered during the period of organogenesis in all three animal species. embryotoxicity was observed in rats, rabbits, and monkeys at oral doses of azelaic acid that generated some maternal toxicity. embryotoxicity was observed in rats given 2500 mg/kg/day [162 times the mrhd based on body surface area (bsa) comparison], rabbits given 150 or 500 mg/kg/day (19 or 65 times the mrhd based on bsa comparison) and cynomolgus monkeys given 500 mg/kg/day (65 times the mrhd based on bsa comparison) azelaic acid. no malformations were observed in the oral embryofetal developmental studies conducted in rats, rabbits and cynomolgus monkeys. an oral peri- and post-natal developmental study was conducted in rats. azelaic acid was administered from gestational day 15 through day 21 postpartum up to a dose level of 2500 mg/kg/day. embryotoxicity was observed in rats at an oral dose of 2500 mg/kg/day (162 times the mrhd based on bsa comparison) that generated some maternal toxicity. in addition, slight disturbances in the post-natal development of fetuses was noted in rats at oral doses that generated some maternal toxicity (500 and 2500 mg/kg/day; 32 and 162 times the mrhd based on bsa comparison). no effects on sexual maturation of the fetuses were noted in this study. risk summary azelaic acid is naturally present in human milk. when used as prescribed, azelaic acid is unlikely to be absorbed through the skin in clinically relevant amounts to cause a change in azelaic acid concentration in milk or milk production; therefore, breastfeeding is not expected to result in exposure of the infant to azelaic acid gel. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for azelaic acid gel and any potential adverse effects on the breastfed child from azelaic acid gel or from the underlying maternal condition. the safety and effectiveness of azelaic acid gel have not been established in pediatric patients. clinical studies of azelaic acid gel did not include sufficient numbers of subjects aged 65 and over to determine if they respond differently than younger subjects.

United States - English - NLM (National Library of Medicine)

sandoz inc. - azelaic acid (unii: f2vw3d43yt) (azelaic acid - unii:f2vw3d43yt) - azelaic acid gel, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. limitations of use although some reduction of erythema which was present in patients with papules and pustules of rosacea occurred in clinical studies, efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated. none. risk summary azelaic acid is minimally absorbed systemically following topical route of administration, and maternal use is not expected to result in fetal exposure to the drug [see clinical pharmacology (12.3)]. in animal reproduction studies, embryofetal toxicity was noted when azelaic acid was administered orally during the period of organogenesis at doses 162, 19, and 65 times the maximum recommended human dose (mrhd) in rats, rabbits, and monkeys, respectively. maternal toxicity was noted at these doses but no malformations were observed in these embryofetal developmental studies (see data). the background risk of ma

United States - English - NLM (National Library of Medicine)

glenmark pharmaceuticals inc., usa - azelaic acid (unii: f2vw3d43yt) (azelaic acid - unii:f2vw3d43yt) - azelaic acid gel, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. limitations of use although some reduction of erythema which was present in patients with papules and pustules of rosacea occurred in clinical studies, efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated. none. risk summary azelaic acid is minimally absorbed systemically following topical route of administration, and maternal use is not expected to result in fetal exposure to the drug [see clinical pharmacology (12.3 )]. in animal reproduction studies, embryofetal toxicity was noted when azelaic acid was administered orally during the period of organogenesis at doses 162, 19, and 65 times the maximum recommended human dose (mrhd) in rats, rabbits, and monkeys, respectively. maternal toxicity was noted at these doses but no malformations were observed in these embryofetal developmental studies (see data). the background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data dermal embryofetal developmental toxicology studies have not been performed with azelaic acid, 15% gel. oral embryofetal developmental studies were conducted with azelaic acid in rats, rabbits, and cynomolgus monkeys. azelaic acid was administered during the period of organogenesis in all three animal species. embryotoxicity was observed in rats, rabbits, and monkeys at oral doses of azelaic acid that generated some maternal toxicity. embryotoxicity was observed in rats given 2500 mg/kg/day [162 times the mrhd based on body surface area (bsa) comparison], rabbits given 150 or 500 mg/kg/day (19 or 65 times the mrhd based on bsa comparison) and cynomolgus monkeys given 500 mg/kg/day (65 times the mrhd based on bsa comparison) azelaic acid. no malformations were observed in the oral embryofetal developmental studies conducted in rats, rabbits and cynomolgus monkeys. an oral peri- and post-natal developmental study was conducted in rats. azelaic acid was administered from gestational day 15 through day 21 postpartum up to a dose level of 2500 mg/kg/day. embryotoxicity was observed in rats at an oral dose of 2500 mg/kg/day (162 times the mrhd based on bsa comparison) that generated some maternal toxicity. in addition, slight disturbances in the post-natal development of fetuses was noted in rats at oral doses that generated some maternal toxicity (500 and 2500 mg/kg/day; 32 and 162 times the mrhd based on bsa comparison). no effects on sexual maturation of the fetuses were noted in this study. risk summary azelaic acid is naturally present in human milk. when used as prescribed, azelaic acid is unlikely to be absorbed through the skin in clinically relevant amounts to cause a change in azelaic acid concentration in milk or milk production; therefore, breastfeeding is not expected to result in exposure of the infant to azelaic acid gel. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for azelaic acid gel and any potential adverse effects on the breastfed child from azelaic acid gel or from the underlying maternal condition. the safety and effectiveness of azelaic acid gel have not been established in pediatric patients. clinical studies of azelaic acid gel did not include sufficient numbers of subjects aged 65 and over to determine if they respond differently than younger subjects.

United States - English - NLM (National Library of Medicine)

taro pharmaceuticals u.s.a., inc. - azelaic acid (unii: f2vw3d43yt) (azelaic acid - unii:f2vw3d43yt) - azelaic acid gel, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. limitations of use although some reduction of erythema which was present in patients with papules and pustules of rosacea occurred in clinical studies, efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated. none. risk summary azelaic acid is minimally absorbed systemically following topical route of administration, and maternal use is not expected to result in fetal exposure to the drug [see clinical pharmacology (12.3)]. in animal reproduction studies, embryofetal toxicity was noted when azelaic acid was administered orally during the period of organogenesis at doses 162, 19, and 65 times the maximum recommended human dose (mrhd) in rats, rabbits, and monkeys, respectively. maternal toxicity was noted at these doses but no malformations were observed in these embryofetal developmental studies (see data). the background risk of maj