Pellix

Pellix is an FDA-registered drug product whose active ingredient is CALCIPOTRIENE. It is labelled by Perfero Pharma, Inc. taken by topical and marketed as a human prescription drug product. Identifiers on file: NDC 87143-300, application ANDA078468, label effective 20260504. It is one of 6 FDA drug label records sharing the active ingredient CALCIPOTRIENE. 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 CALCIPOTRIENE are most often described in connection with: usage pellix, calcipotriene topical, solution scalp, treatment chronic, moderately severe. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

INDICATIONS AND USAGE Pellix™ (calcipotriene) Topical Solution, 0.005% (Scalp Solution) is indicated for the topical treatment of chronic, moderately severe psoriasis of the scalp. The safety and effectiveness of topical calcipotriene in dermatoses other than psoriasis have not been established.

DOSAGE AND ADMINISTRATION Comb the hair to remove scaly debris and after suitably parting, apply Pellix™ Topical Solution, 0.005% (Scalp Solution), twice daily, only to the lesions, and rub in gently and completely, taking care to prevent the solution spreading onto the forehead. The safety and efficacy of Pellix™ Topical Solution, 0.005% (Scalp Solution), have been demonstrated in patients treated for eight weeks. Keep Pellix™ Topical Solution, 0.005% (Scalp Solution), well away from the eyes. Avoid application of the solution to uninvolved scalp margins. Always wash hands thoroughly after use.

CONTRAINDICATIONS Pellix™ Topical Solution, 0.005% (Scalp Solution), is contraindicated in those patients with acute psoriatic eruptions or a history of hypersensitivity to any of the components of the preparation. It should not be used by patients with demonstrated hypercalcemia or evidence of vitamin D toxicity.

WARNINGS Avoid contact with the eyes or mucous membranes. Discontinue use if a sensitivity reaction occurs or if excessive irritation develops on uninvolved skin areas. Drug product is flammable. Keep away from open flame.

ADVERSE REACTIONS In controlled clinical trials, the most frequent adverse reactions reported to be related to Pellix™ Topical Solution, 0.005% (Scalp Solution), use were transient burning, stinging and tingling, which occurred in approximately 23% of patients. Rash was reported in about 11% of patients. Dry skin, irritation and worsening of psoriasis were reported in 1-5% of patients, Skin atrophy, hyperpigmentation, hypercalcemia, and folliculitis were not observed in these studies, but cannot be excluded. To report SUSPECTED ADVERSE REACTIONS, contact Perfero Pharma, Inc. at 1-973-629-0109 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

FDA lists 6 drug label records with CALCIPOTRIENE 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.

What is Pellix used for?
INDICATIONS AND USAGE Pellix™ (calcipotriene) Topical Solution, 0.005% (Scalp Solution) is indicated for the topical treatment of chronic, moderately severe psoriasis of the scalp. The safety and effectiveness of topical calcipotriene in dermatoses other than psoriasis have not been established.

Who makes Pellix?
Perfero Pharma, Inc. is the labeler of record for Pellix. 6 FDA label records share the active ingredient CALCIPOTRIENE, 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 Pellix 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 Pellix 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 CALCIPOTRIENE?
Yes. 6 FDA drug label records list CALCIPOTRIENE 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 Pellix been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

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.