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2014年国外新批准的皮肤科治疗药物(一)
2017-10-10 08:28:00 来源: 作者: 【 】 浏览:1632次 评论:0
抗痤疮药
Clindamycin phosphate 1.2% + benzoyl peroxide 3.75% gelOnexton™
Valeant PharmaceuticalsApproval was granted to this once-daily topical treatment of comedonal (noninflammatory) and inflammatory acne. This fixed combination of a lincosamide antibacterial agent and an antimicrobial is indicated for the treatment of acne vulgaris in patients ≥12 years of age.US FDADoxycycline hyclate tablets
Acticlate™
Aqua Pharmaceuticals AlmirallThis tetracycline-class antimicrobial agent was approved for treating a number of infections including adjunctive therapy in severe acne. Several dosing options are available with film-coated round 75 mg tablets and oval-shaped dual-scored 150 mg tablets.US FDATretinoin gel microsphere 0.08%
Retin-A Micro®
Valeant PharmaceuticalsApproval of a Supplemental New Drug Application (sNDA) was granted for Retin-A Micro® gel microsphere 0.08% for the topical treatment of acne vulgaris. Retin-A Micro® gel is already available in 0.04% and 0.1% strengths.US FDA
Actinic Keratosis
Dalbavancin IV injection
Dalvance™
Durata TherapeuticsDalbavancin, a novel second generation lipoglycopeptide antibiotic, was approved for the treatment of adults with skin infections. Treatment is indicated for acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible strains of Gram-positive microorganisms, such as Staphylococcus aureus (including methicillin-susceptible and methicillin resistant strains) and Streptococcus pyogenes.US FDADalbavancin IV injection
Orbactiv™
The Medicines CompanyApproval was granted for this novel semi-synthetic glycopeptide antibiotic for treating adults with ABSSSI caused by certain susceptible bacteria, including Staphylococcus aureus (including methicillin-susceptible and methicillin resistant strains), various Streptococcus species and Enterococcus faecalis.US FDATedizolid phosphate tablets & IV injection
Sivextro™
Cubist PharmaceuticalsTedizolid, a novel oxazolidinone-class antibacterial agent, was approved for the treatment of adult ABSSSI caused by susceptible Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA).US FDAMetronidazole 1.3% vaginal gel
Actavis plc
Valeant PharmaceuticalsA New Drug Application (NDA) for metronidazole 1.3% vaginal gel, a nitroimidazole antibiotic, was approved for the treatment of bacterial vaginosis (BV) in non-pregnant women. This preparation of metronidazole offers a convenient single-dose treatment for BV that is packaged in a pre-filled disposable applicator.US FDA
Antifungal Agents
抗真菌
Efinaconazole 10% topical solution
Jublia®
Valeant PharmaceuticalsApproval was granted to this antifungal compound for the treatment of mild to moderate onychomycosis. It is the first topical triazole antifungal agent developed for distal lateral subungual onychomycosis (DLSO).US FDANaftifine HCl 2% gel & cream
Naftin®
Merz DermatologyNaftin® (naftifine HCl) 2% gel and cream formulations received approval for the treatment of interdigital type tinea pedis in pediatric patients aged 12-17 years. This pediatric approval expands the previous labelling that indicated use in patients >18 years of age.US FDATavaborole 5% topical solution
Kerydin™
Anacor PharmaceuticalsTavaborole, the first oxaborole antifungal agent, was a
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