Latest News - FDA Approval/Clearance

Tuesday, November 06, 2018

US FDA Grants Dupixent Priority Review for Moderate-to-Severe AD in Adolescents

The US Food and Drug Administration (FDA) has granted Priority Review for Dupixent (dupilumab) as a potential treatment for adolescents with uncontrolled moderate-to-severe atopic dermatitis (AD). …

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Monday, November 05, 2018

FDA Approves Galderma’s Restylane Lyft for Midface Injection Via Cannula

The U.S. Food and Drug Administration (FDA) has approved the use of Galderma’s Restylane Lyft with a small, blunt-tip cannula for cheek augmentation and the correction of age-related midface con…

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Thursday, October 11, 2018

Study: Positive Safety and Tolerability Results for Ortho Dermatologics' Altreno for Acne

Ortho Dermatologics shared results of two identical Phase 3, multicenter, randomized, double-blind, vehicle-controlled, parallel group studies examining the efficacy and safety of Altreno (tretinoin) …

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Monday, October 08, 2018

Ortho Dermatologics Receives Tentative FDA Approval for Bryhali for Plaque Psoriasis

The FDA has provided tentative approval of the New Drug Application for Bryhali (halobetasol propionate) Lotion, 0.01%, for the topical treatment of plaque psoriasis in adult patients. Bryhali Lotion …

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Wednesday, October 03, 2018

FDA Approves Paratek's Nuzyra

The FDA has approved Paratek Pharmaceuticals, Inc's Nuzyra (omadacycline) for the treatment of adults with community-acquired bacterial pneumonia (CABP) and acute skin and skin structure infection…

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Wednesday, October 03, 2018

Dermira’s Qbrexa Cloth Now Available for Primary Axillary Hyperhidrosis

Dermira, Inc.'s Qbrexa (glycopyrronium) cloth is now available for prescribing to treat primary axillary hyperhidrosis. The new therapy is available in retail and community pharmacies nationwide. …

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Tuesday, October 02, 2018

Seysara: Oral Antibiotic is First Approved for Dermatology in 40 Years

Seysara (sarecycline), a new, first in class tetracycline-derived oral antibiotic, is now approved for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients…

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Friday, September 28, 2018

FDA Approves Regeneron's Libtayo, First Treatment for Metastatic or Locally Advanced SCC

Libtayo (cemiplimab-rwlc) injection (Regeneron Pharmaceuticals, Inc.)  is now FDA-approved for intravenous use for the treatment of patients with metastatic cutaneous squamous cell carcinoma…

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Friday, September 21, 2018

FDA Green Lights First Spray-on-Skin Product for Burns

The US Food and Drug Administration granted premarket approval to Avita Medical’s Recell, a spray-on-skin that treats second- and third-degree burns in patients aged older than 18 years. The …

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Tuesday, September 18, 2018

FDA Clears Sebacia Microparticles for Laser-Based Acne Treatment

Sebacia Microparticles are now FDA-cleared for use in the treatment of acne. The clearance comes on the heels of a pivotal study demonstrating the clinical safety and efficacy of the micoparticles. Se…

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Wednesday, September 05, 2018

New from Thermi: Meet the Arvati Platform

Thermi, an Almirall company, is launching Arvati, a next-generation 510K US Food and Drug Administration-cleared, true temperature-controlled radiofrequency platform that powers a range of Thermi proc…

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Wednesday, August 29, 2018

FDA Accepts Ortho Derm's Resubmission of NDA for Duobrii Lotion for Plaque Psoriasis

The FDA has accepted Ortho Dermatologics' resubmitted New Drug Application (NDA) for Duobrii (halobetasol propionate and tazarotene) (IDP-118) Lotion for the topical treatment of plaque psoriasis.…

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Monday, August 27, 2018

Latest on Compounding: FDA Proposes to Strike Three Bulk Drug Substances from List

The FDA has issued a Federal Register notice proposing not to include three bulk drug substances, bumetanide, nicardipine hydrochloride, and vasopressin, on the list of bulk drug substances …

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Friday, August 24, 2018

FDA Nod for Ortho Derm’s Acne Lotion Altreno

The U.S. Food and Drug Administration (FDA) approved the New Drug Application for Ortho Dermatologic’s Altreno (tretinoin 0.05%) lotion, indicated for the topical treatment of acne vulgaris in p…

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Thursday, August 23, 2018

Lupin Launches Generic Clobetasol Cream in the US

Lupin has launched its Clobetasol Propionate Cream 0.05%, having received approval from the FDA earlier. Lupin's Clobetasol Propionate Cream USP 0.05% is the generic equivalent of Fougera Pharmac…

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