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Five recent FDA approvals in dermatology

Recent FDA actions involving dermatology include approvals of Finacea Foam, 15% for treating papulopustular rosacea and Odomzo for locally advanced basal cell carcinoma.

Other recent FDA approvals include antibiotic-free Epiduo Forte Gel, 03.5%/2.5% for acne vulgaris and Restylane Lyft for cheek augmentation:

FDA approves Finacea Foam, 15% for treating papulopustular rosacea

Bayer HealthCare announced in a press release that the FDA has approved Finacea Foam, 15% as topical treatment of mild to moderate papulopustular rosacea.

The FDA based the approval on results of two clinical trials that examined the efficacy and safety of Finacea (azelaic acid) Foam, 15% compared with the foam vehicle without azelaic acid as topical treatment of papulopustular rosacea, according to the press release. Read more

FDA approves antibiotic-free gel treatment for acne

The FDA has approved antibiotic-free Epiduo Forte Gel, 0.3%/2.5%, for once-daily, topical treatment of acne vulgaris, according to a press release from Galderma.

Jonathan Weiss

"Epiduo Forte Gel is an effective and well-tolerated antibiotic-free treatment option for the moderate to severe acne patient," Jonathan Weiss, MD, a board certified dermatologist at Gwinnett Dermatology, P.C. and a clinical investigator for the phase 3 trial of Epiduo Forte Gel, told Healio.com/Dermatology. "It contains the highest-available concentration of adapalene combined with benzoyl peroxide.” Read more

FDA approves Odomzo for locally advanced basal cell carcinoma

The FDA today announced the approval of Odomzo for the treatment of patients with locally advanced basal cell carcinoma.

Odomzo (sonidegib, Novartis Pharmaceuticals) is indicated for patients whose basal cell carcinoma has advanced following surgery or radiation therapy, or for patients who are not candidates for surgery or radiation. Read more

FDA approves Restylane Lyft for cheek augmentation

The FDA has granted market approval to Restylane Lyft with lidocaine for cheek augmentation and correction of age-related midface contour deficiencies in adults aged at least 21 years, according to a press release from Galderma.

The injectable gel used to increase volume and smooth facial wrinkles was formerly marketed as Perlane-L, the release stated. The new indication makes it the only FDA-approved filler to provide midface-area fullness and to correct and smooth nasolabial folds, according to the release. Read more

FDA approves Radiesse for hand augmentation

The FDA has approved Radiesse, an opaque dermal filler composed of calcium hydroxyapatite microspheres suspended in a water-based gel carrier, for hand augmentation to improve volume loss in the dorsum of hands, according to Merz North America.

Mitchel Goldman

“Hands have been a real unmet need in cosmetic surgery,” Mitchel Goldman, MD, founder and medical director of Cosmetic Laser Dermatology, San Diego, who was a researcher in the clinical trial, said in a separate press release. Read more