| Name/Company | Approval Dates and Comments |
|
Human papillomavirus 9-valent vaccine, recombinant Gardasil®9 |
In December 2014, the US FDA approved this 9-valent human papillomavirus (HPV) vaccine 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. It 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. |
|
Ivermectin 1% cream Soolantra® |
The FDA approved ivermectin 1% cream in December 2014 for the once-daily topical treatment of inflammatory lesions, or bumps and pimples, of rosacea. The exact cause of rosacea is unknown, but multiple triggers have been implicated, including the over-proliferation of Demodex mites in the skin. Ivermectin has both anti-inflammatory and antiparasitic activities. Phase 3 clinical investigations observed onset of action as early as week 2 with continuous improvement. In long-term extensions to 12-week studies, ivermectin 1% cream demonstrated safety and tolerability for an additional 40 weeks (up to 52 weeks in total). |
|
Naftifine HCl 2% gel & cream Naftin® |
The FDA approved a pediatric indication for naftifine HCl (an allylamine antifungal) 2% cream and gel formulations in December 2014 for the treatment of interdigital type tinea pedis in patients aged 12-17 years. |
|
Nivolumab IV infusion Opdivo® |
The FDA approved this human programmed death receptor-1 (PD-1) blocking monoclonal antibody in December 2014 for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab (Yervoy®) and, if BRAF V600 mutation positive, a BRAF inhibitor. This indication was granted under accelerated approval based on tumor response rate and durability of response. |
|
Polymethylmethacrylate collagen dermal filler for acne scars Bellafill® |
The FDA approved this dermal filler in January 2015 for the treatment of acne scars. Bellafill® is the only injectable filler sanctioned for this indication. The product was studied extensively prior to gaining regulatory approval and shown to be safe and effective for the correction of moderate to severe, atrophic, distensible facial acne scars on the cheek in patients >21 years of age. |
|
Secukinumab SC injection Consentyx™ |
The FDA approved secukinumab in January 2015 for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy, or a combination of both. Secukinumab is a fully human monoclonal antibody that inhibits the proinflammatory cytokine interleukin 17A (IL-17A). It is the first approved antipsoriatic agent to selectively bind to IL-17A and inhibit interaction with the IL-17 receptor, thereby suppressing inflammatory responses. The approval is based on the efficacy and safety outcomes from ten Phase 2 and Phase 3 studies, including over 3,990 adult patients with moderate to severe plaque psoriasis, which demonstrated that secukinumab resulted in clear or almost clear skin in the majority of patients and had an acceptable safety profile. |
