pproved for the topical treatment of onychomycosis of the toenails caused by Trichophyton rubrum or Trichophyton mentagrophytes. This clear, colorless, alcohol-based solution is applied with a dropper to the infected toenail once daily for 48 weeks.US FDA
Antiparasitic Agent
抗寄生虫
Miltefosine capsules
Impavido®
Paladin Labs Inc.
Knight Therapeutics Inc.Approval was granted to this oral alkylphosphocholine antiparasitic agent for the treatment of three main types of leishmaniasis: visceral leishmaniasis (affects internal organs), cutaneous leishmaniasis (affects the skin) and mucosal leishmaniasis (affects the nose and throat). It is intended for use in patients ≥12 years of age. Impavido® is the first FDA-approved drug to treat cutaneous or mucosal leishmaniasis.US FDAAntiviral Agent（抗病毒）Human papillomavirus 9-valent vaccine, recombinant
Gardasil®9
MerckThis 9-valent human papillomavirus (HPV) vaccine was approved for use in girls and young women 9-26 years of age for the prevention of cervical, vulvar, vaginal, and anal cancers caused by HPV types 16, 18, 31, 33, 45, 52 and 58, pre-cancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58, and genital warts caused by HPV types 6 and 11. Gardasil®9 is also approved for use in boys 9-15 years of age for the prevention of anal cancer caused by HPV types 16, 18, 31, 33, 45, 52 and 58, precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58, and genital warts caused by HPV types 6 and 11. Gardasil®9 includes the greatest number of HPV types in any available HPV vaccine.US FDADermal FillerHyaluronic acid-based dermal filler
Restylane® Silk
Valeant Pharmaceuticals
(In July 2014, all rights to Restylane® were sold by Valeant to Galderma)Marketing clearance was granted for Restylane® Silk injectable gel with 0.3% lidocaine, a device indicated for submucosal implantation for lip augmentation and dermal implantation for the correction of perioral rhytids in patients >21 years of age.US FDADupuytren's ContractureCollagenase clostridium histolyticum for injection
Xiaflex®
Auxilium Pharmaceuticals BioSpecificsA supplemental Biologics License Application (sBLA) was approved for this novel, first-in-class biologic for the treatment of up to two Dupuytren's contracture cords in the same hand during a single treatment visit. Xiaflex® obtained FDA approval in 2010 as the first and only nonsurgical treatment for adult Dupuytren's contracture patients with a palpable cord in the palm.US FDA
Hemangioma、
血管瘤
Propranolol hydrochloride oral solution
Hemangeol™
Pierre Fabre DermatologieThe first and only beta-blocker formulation was approved for the treatment of proliferating infantile hemangioma requiring systemic therapy. Hemangeol™, specifically developed for use in pediatric patients, was studied in infants aged 5 weeks to 5 months (at therapy initiation). The treatment protocol of 3 mg/kg/day for 6 months demonstrated a 60.4% success rate vs. 3.6% in the placebo group, achieving the primary endpoint of complete or nearly-complete resolution.US FDA
Hereditary Angioedema
遗传性血管性水肿
C1 esterase inhibitor IV infusion
Ruconest®
Pharming Group NV
Salix PharmaceuticalsThe first recombinant human C1 esterase inhibitor was approved for the treatment of acute angioedema attacks in adult and adolescent patients with acute here |
