Acanya

Acanya is an FDA-registered drug product whose active ingredient is CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE. It is labelled by Bausch Health US, LLC taken by topical and marketed as a human prescription drug product. Identifiers on file: NDC 13548-132, application NDA050819, label effective 20200930. It is one of 5 FDA drug label records sharing the active ingredient CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE are most often described in connection with: acanya gel, topical treatment, acne vulgaris, patients years, combination clindamycin, phosphate lincosamide, benzoyl peroxide. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE ACANYA ® Gel is indicated for the topical treatment of acne vulgaris in patients 12 years or older. ACANYA Gel is a combination of clindamycin phosphate (a lincosamide antibacterial) and benzoyl peroxide indicated for the topical treatment of acne vulgaris in patients 12 years or older. ( 1 )

2 DOSAGE AND ADMINISTRATION Before applying ACANYA Gel, wash your face gently with a mild soap, rinse with warm water, and pat your skin dry. Apply a pea-sized amount of ACANYA Gel to the face once daily. Avoid the eyes, mouth, mucous membranes, or areas of broken skin. Use of ACANYA Gel beyond 12 weeks has not been evaluated. Concomitant topical acne therapy should be used with caution because a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating, or abrasive agents. ACANYA Gel is not for oral, ophthalmic, or intravaginal use. • Apply a pea-sized amount of ACANYA Gel to the face once daily. ( 2 ) • Not for oral, ophthalmic, or intravaginal use. ( 2 )

4 CONTRAINDICATIONS ACANYA Gel is contraindicated in: • Patients who have demonstrated hypersensitivity (e.g., anaphylaxis) to clindamycin, benzoyl peroxide, any components of the formulation, or lincomycin. ( 4.1 ) • Patients with a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis. ( 4.2 ) 4.1 Hypersensitivity ACANYA Gel is contraindicated in those individuals who have shown hypersensitivity to clindamycin, benzoyl peroxide, any components of the formulation, or lincomycin. Anaphylaxis, as well as allergic reactions leading to hospitalization, has been reported in postmarketing use with ACANYA Gel [see Postmarketing Experience (6.2) ] . 4.2 Colitis/Enteritis ACANYA Gel is contraindicated in patients with a history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis [see Warnings and Precautions (5.1) ] .

6 ADVERSE REACTIONS The following selected adverse reactions occurred in less than 0.2% of patients: application site pain (0.1%); application site exfoliation (0.1%); and application site irritation (0.1%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reactions observed in the clinical trials of a drug cannot always be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The following selected adverse reactions occurred in less than 0.2% of subjects treated with ACANYA Gel: application site pain (0.1%); application site exfoliation (0.1%); and application site irritation (0.1%). During clinical trials, subjects were assessed for local cutaneous signs and symptoms of erythema, scaling, itching, burning and stinging. Most local skin reactions increased and peaked around Week 4 and continually decreased over time reaching near baseline levels by Week 12. The percentage of subjects that had symptoms present before treatment, the maximum value recorded during treatment, and the percent with symptoms present at Week 12 are shown in Table 1. Table 1: Percent of Subjects with Local Skin Reactions. Combined Results from the Two Phase 3 Trials (N = 773) Before Treatment (Baseline) Maximum During Treatment End of Treatment (Week 12) Mild Mod.* Severe Mild Mod.* Severe Mild Mod.* Severe Erythema 22 4 0 25 5 < 1 15 2 0 Scaling 8 < 1 0 18 3 0 8 1 0 Itching 10 2 0 15 2 0 6 < 1 0 Burning 3 < 1 0 8 2 0 2 < 1 0 Stinging 2 < 1 0 6 1 0 1 < 1 0 6.2 Postmarketing Experience Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Anaphylaxis, as well as allergic reactions leading to hospitalizations, has been reported in postmarketing use of products containing clindamycin/benzoyl peroxide.

FDA lists 5 drug label records with CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

1 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Acanya used for?
1 INDICATIONS AND USAGE ACANYA ® Gel is indicated for the topical treatment of acne vulgaris in patients 12 years or older. ACANYA Gel is a combination of clindamycin phosphate (a lincosamide antibacterial) and benzoyl peroxide indicated for the topical treatment of acne vulgaris in patients 12 years or older. ( 1 )

Who makes Acanya?
Bausch Health US, LLC is the labeler of record for Acanya. 5 FDA label records share the active ingredient CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Acanya come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Acanya prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE?
Yes. 5 FDA drug label records list CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Acanya been recalled?
1 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.