Halobetasol Propionate (Bryhali)

Trade Name : Bryhali

Bausch Health Americas Inc.

LOTION

Strength 0.1 mg/g

HALOBETASOL PROPIONATE Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]

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Wholesalers Suppliers Exporters Doctors MOH Tender Supplies Hospitals Brand CROs Comparator Supplies Generic Cooperate Sourcing Individual Patients Indian Institutional Buyers

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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 Halobetasol Propionate (Bryhali) which is also known as Bryhali and Manufactured by Bausch Health Americas Inc.. It is available in strength of 0.1 mg/g per ml. Read more

Halobetasol Propionate (Bryhali) 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

Packaging and Delivery

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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

No data

BRYHALI(halobetasol propionate) lotion, 0.01% is indicated for the topical treatment of plaque psoriasis in adults.
BRYHALI lotion is a corticosteroid indicated for the topical treatment of plaque psoriasis in adults. ()

Apply a thin layer of BRYHALI Lotion to affected areas once daily. Rub in gently. Wash hands after each application, unless BRYHALI Lotion is for treatment of the hands.
BRYHALI Lotion treatment beyond 8 weeks is not recommended, and the total dosage should not exceed approximately 50 g per week. Discontinue treatment if control is achieved before 8 weeks. Do not use with occlusive dressings unless directed by a physician.
BRYHALI Lotion should not be used on the face, groin, or in the axillae.
BRYHALI Lotion is not for oral, ophthalmic, or intravaginal use.

Lotion, 0.01%
Each gram of BRYHALI Lotion contains 0.1 mg (0.01%) halobetasol propionate in a white to off-white lotion.
Lotion, 0.01% (3)
Each gram of BRYHALI Lotion contains 0.1 mg (0.01%) halobetasol propionate. ()

None.

u00a0

No data

5.1n- 8.4

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
In randomized, double-blind, multicenter, vehicle-controlled clinical trials, 426 adults with plaque psoriasis were treated with BRYHALI Lotion and had post-baseline safety data. Subjects applied BRYHALI Lotion once daily for up to 8 weeks. Table 1 presents adverse reactions that occurred in at least 1% of subjects treated with BRYHALI Lotion and more frequently than in vehicle-treated subjects.
To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health Americas, Inc. at 1-800-321-4576 or FDA at 1-800-FDA-1088 or n

u2022
6.1

No data

BRYHALI (halobetasol propionate) lotion contains a corticosteroid, halobetasol propionate, as the active ingredient in a white to off-white lotion formulation intended for topical use.
Halobetasol propionate is a synthetic corticosteroid. The chemical name for halobetasol propionate is 21-chloro-6u03b1, 9-difluoro-11u03b2, 17-dihydroxy-16u03b2-methylpregna-1, 4-diene-3, 20 u2013dione, 17-propionate. Halobetasol propionate is a white to off-white crystalline powder with a molecular weight of 484.96 and a molecular formula of CHClFO. It is practically insoluble in water and freely soluble in dichloromethane and in acetone. The structural formula for halobetasol propionate is represented below:
Each gram of BRYHALI Lotion contains 0.1 mg (0.01%) halobetasol propionate in a white to off-white lotion base consisting of carbomer copolymer type B, carbomer homopolymer type A, diethyl sebacate, edetate disodium dihydrate, light mineral oil, methylparaben, propylparaben, purified water, sodium hydroxide, sorbitan monooleate and sorbitol solution, 70%.

No data

Long-term animal studies have not been performed to evaluate the carcinogenic potential of halobetasol propionate.
Halobetasol propionate was not genotoxic in the Ames assay, in the sister chromatid exchange test in Chinese hamster somatic cells, in chromosome aberration studies of germinal and somatic cells of rodents, or in a mammalian spot test. Positive mutagenicity effects were observed in a mouse lymphoma gene mutation assay in vitro and in a Chinese hamster micronucleus test.
Studies in rats following oral administration of halobetasol propionate at dose levels up to 0.05 mg/kg/day indicated no impairment of fertility or general reproductive performance.

BRYHALI Lotion was evaluated for the treatment of moderate to severe plaque psoriasis in two prospective, multicenter, randomized, double-blind clinical trials (Trial 1 [NCT02514577] and Trial 2 [NCT02515097]). These trials were conducted in 430 subjects 18 years of age and older with moderate to severe plaque psoriasis that covered a body surface area (BSA) between 3% and 12% excluding the face, scalp, palms, soles, axillae, and intertriginous areas. Disease severity was determined by a five-grade Investigatoru2019s Global Assessment (IGA). Subjects applied BRYHALI Lotion or vehicle to all affected areas once daily for up to 8 weeks. Subjects had a follow-up visit 4 weeks after the end of treatment (Week 12) where safety and efficacy were evaluated.
The primary efficacy endpoint was the proportion of subjects with treatment success at Week 8, where treatment success was defined as at least a 2-grade improvement from baseline in IGA score and an IGA score equating to u201cclearu201d or u201calmost clearu201d. Table 2 lists the primary efficacy results for Trials 1 and 2. The secondary efficacy endpoints evaluated treatment success sequentially at Weeks 12, 6, 4, and 2. Figure 1 shows the primary and secondary efficacy results over time.

BRYHALI (halobetasol propionate) lotion, 0.01% is a white to off-white lotion supplied in a white aluminum tube as follows:
Storage and Handling Conditions
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F); excursions permitted to 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F) [see USP Controlled Room Temperature]. Protect from freezing.

Advise the patient to read the FDA-approved patient labeling (Patient Information).
This information is intended to aid in the safe and effective use of this medication. It is not a disclosure of all administration instructions or all possible adverse or unintended effects.
Advise patients using BRYHALI Lotion of the following information and instructions:
Important Administration Instructions
Instruct patients to discontinue BRYHALI Lotion when psoriasis is controlled. Inform patients that BRYHALI Lotion is to be used as directed by the physician and should not be used for longer than the prescribed time period. Total dosage should not exceed 50 grams per week .
Instruct patients to avoid bandaging, wrapping or otherwise occluding the treatment area(s), unless directed by physician. Advise patients to avoid use on the face, groin, or axillae .
Inform patients that BRYHALI Lotion is for external use only. Advise patients that BRYHALI Lotion is not for oral, ophthalmic, or intravaginal use n
Breastfeeding women should not apply BRYHALI Lotion directly to the nipple and areola to avoid directly exposing the infant .
Effects on Endocrine System
BRYHALI Lotion may cause HPA axis suppression. Advise patients that use of topical corticosteroids, including BRYHALI Lotion, may require periodic evaluation for HPA axis suppression. Topical corticosteroids may have other endocrine effects. Concomitant use of multiple corticosteroid-containing products may increase the total systemic exposure to topical corticosteroids .
Local Adverse Reactions
Inform patients that BRYHALI Lotion may cause local adverse reactions. These reactions may be more likely to occur with occlusive use or prolonged use of BRYHALI Lotion n
Manufactured for:n
Manufactured by:n
U.S. Patent Numbers: 6,517,847 and 8,809,307
BRYHALI is a trademark of Bausch Health Companies Inc. or its affiliates.
u00a9 2019 Bausch health Companies Inc. or its affiliatesn 9652103

PATIENT INFORMATION
BRYHALI (bry-HAL-ee)
(halobetasol propionate) Lotion
Important: BRYHALI is for use on the skin only
What is BRYHALI?
BRYHALI is a prescription corticosteroid medicine used on the skin (topical) to treat adults with plaque psoriasis.
It is not known if BRYHALI is safe and effective in children under 18 years of age.
Before using BRYHALI, tell your doctor about all of your medical conditions, including if you:
Tell your doctor about all the medicines you take,
How should I use BRYHALI?
What are the possible side effects of BRYHALI?
BRYHALI may cause serious side effects, including:
The most common side effects of BRYHALI include
These are not all the possible side effects of BRYHALI.
Call your doctor for medical advice about side effects. You may report side effects to
How should I store BRYHALI?
General information about the safe and effective use of BRYHALI.
What are the ingredients in BRYHALI?
Active ingredients:
Inactive ingredients:
Manufactured for:n- Manufactured by:
U.S. Patent Numbers: 6,517,847 and 8,809,307
BRYHALI is a trademark of Bausch Health Companies Inc. or its affiliates.
u00a9 2019 Bausch Health Companies Inc. or its affiliates

NDC
For Topical Use Onlyn- Not for Eye Use
BRYHALIn n- (halobetasol propionate) Lotion, 0.01%
Rx only
Net Wt. 100 g
Ortho Dermatologics

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Halobetasol Propionate (Bryhali)

Trade Name : Bryhali

LOTION

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

About GNH

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Halobetasol Propionate (Bryhali)

Trade Name : Bryhali

LOTION

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

Can’t find what you’re looking for?

COMPANY

SERVICES

QUICK LINKS

CONTACT US

Can’t find what
you’re looking for?