Azelaic Acid (Azelaic Acid)

Trade Name : azelaic acid

Actavis Pharma, Inc.

GEL

Strength 0.15 g/g

AZELAIC ACID Decreased Protein Synthesis [PE],Decreased Sebaceous Gland Activity [PE]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Azelaic Acid (Azelaic Acid) which is also known as azelaic acid and Manufactured by Actavis Pharma, Inc.. It is available in strength of 0.15 g/g per ml. Read more

Azelaic Acid (Azelaic Acid) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • 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.
  • Azelaic acid gel, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. Efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated. ()
  • No data
  • Azelaic acid gel, 15% is a white to off-white homogeneous gel. Each gram of azelaic acid gel contains 0.15 gm of azelaic acid (15% w/w).
  • Gel, 15% ()
  • None.
  • None. ()
  • No data
  • Hypersensitivityn- 5.1
  • Skin Reactions:u00a0n- 5.2
  • Hypopigmentation: n- 5.2
  • Eye and Mucous Membrane Irritation:u00a0n- 5.3
  • Exacerbation of Asthma: n- 5.4
  • The most common adverse reactions are burning/stinging/tingling (29%), pruritus (11%), scaling/dry skin/xerosis (8%) and erythema/irritation (4%). ()
  • To report SUSPECTED ADVERSE REACTIONS, contact n u00a0or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • u00a0
  • There have been no formal studies of the interaction of azelaic acid gel with other drugs.
  • No data
  • Azelaic acid gel 15%, is an aqueous gel which contains azelaic acid, a naturally-occurring saturated dicarboxylic acid. Chemically, azelaic acid is 1,7-heptanedicarboxylic acid. The molecular formula for azelaic acid is CHO. It has the following structure:
  • Azelaic acid has a molecular weight of 188.22. It is a white, odorless crystalline solid. It is poorly soluble in water at 20u00b0C (0.24%) but freely soluble in boiling water and in ethanol.
  • Azelaic acid gel is a white to off-white homogeneous gel for topical use; each gram contains 0.15 gm azelaic acid (15% w/w) in an aqueous gel base containing benzoic acid (as a preservative), carbopol 980, edetate disodium, glycerol monooleate, lecithin, polysorbate 80, propylene glycol, purified water, and sodium hydroxide to adjust pH.
  • No data
  • Systemic long-term animal studies have not been performed to evaluate the carcinogenic potential of azelaic acid. In a 26-week dermal carcinogenicity study using transgenic (Tg.AC) mice, azelaic acid gel and the gel vehicle, when applied once or twice daily, did not increase the number of female Tg.AC animals with papillomas at the treatment site. No statistically significant increase in the number of animals with papillomas at the treatment site was observed in male Tg.AC animals after once daily application. After twice daily application, azelaic acid gel and the gel vehicle induced a statistically significant increase in the number of male animals with papillomas at the treatment site when compared to untreated males. This suggests that the positive effect may be associated with the vehicle application. The clinical relevance of the findings in animals to humans is not clear.
  • Azelaic acid was not mutagenic or clastogenic in a battery of [Ames assay, HGPRT in V79 cells (Chinese hamster lung cells), and chromosomal aberration assay in human lymphocytes] and (dominant lethal assay in mice and mouse micronucleus assay) genotoxicity tests.
  • Oral administration of azelaic acid at dose levels up to 2500 mg/kg/day (162 times the MRHD based on BSA) did not affect fertility or reproductive performance in male or female rats.
  • Azelaic acid gel was evaluated for the treatment of mild to moderate papulopustular rosacea in two multicenter, randomized, double-blind, vehicle-controlled, 12-week clinical trials having identical protocols and involving a total of 664 (active: 333; vehicle: 331) subjects aged 21 to 86 years (mean age = 49). Overall, 92.5% of subjects were Caucasian and 73% of subjects were female. Enrolled subjects had mild to moderate rosacea with a mean lesion count of 18 (range 8 to 60) inflammatory papules and pustules. The following subjects were excluded: a) those without papules and pustules; b) those with nodules, rhinophyma, or ocular involvement and c) those with a history of hypersensitivity to propylene glycol or to any other ingredients of the study drug. Azelaic acid gel or its vehicle were to be applied twice daily for 12 weeks; no other topical or systemic medication affecting the course of rosacea and/or evaluability was to be used during the studies. Subjects were instructed to avoid spicy foods, thermally hot food/drink and alcoholic beverages during the study. Subjects were also instructed to use only very mild soaps or soapless cleansing lotion for facial cleansing.
  • The primary efficacy endpoints included both 1) change from baseline in inflammatory lesion counts as well as 2) success defined as a score of u201cclearu201d or u201cminimalu201d with at least a 2-step reduction from baseline on the Investigatoru2019s Global Assessment (IGA), defined as follows below:
  • CLEAR:
  • No papules and/or pustules; no or residual erythema; no or mild to moderate telangiectasia
  • MINIMAL:
  • Rare papules and/or pustules; residual to mild erythema; mild to moderate telangiectasia
  • MILD:
  • Few papules and/or pustules; mild erythema; mild to moderate telangiectasia
  • MILD TO MODERATE:
  • Distinct number of papules and/or pustules; mild to moderate erythema; mild to moderate telangiectasia
  • MODERATE:
  • Pronounced number of papules and/or pustules; moderate erythema; mild to moderate telangiectasia
  • MODERATE TO SEVERE:
  • Many papules and/or pustules, occasionally with large inflamed lesions; moderate erythema; moderate degree of telangiectasia
  • SEVERE:
  • Numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions; moderate or severe erythema; moderate or severe telangiectasia
  • Primary efficacy assessment was based on the u201cintent-to-treatu201d (ITT) population with the u201clast observation carried forwardu201d (LOCF).
  • Both trials demonstrated a statistically significant difference in favor of azelaic acid gel over its vehicle in both reducing the number of inflammatory papules and pustules associated with rosacea (Table 2) as well as demonstrating success on the IGA in the ITT-LOCF population at the end of treatment.
  • Although some reduction of erythema which was present in subjects with papules and pustules of rosacea occurred in clinical trials, efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated.
  • Azelaic acid gel was superior to the vehicle with regard to success based on the IGA of rosacea on a 7-point static score at the end of treatment (ITT population; Table 3).
  • No data
  • Inform patients using azelaic acid gel of the following information and instructions:
  • Teva Pharmaceuticals USA, Inc.n
  • Iss. 6/2018
  • NDC 0591-2131-55
  • Rx only
  • Azelaic Acid Gel,u00a015 %
  • For Topical Use Only u2013 Not for Oral, Ophthalmic, or Intravaginal Use
  • Contains 50 grams
  • TEVA

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