|Name/Company||Approval Dates and Comments|
Metronidazole 1.3% vaginal gel
In March 2014, the US FDA approved a New Drug Application (NDA) for metronidazole 1.3% vaginal gel, a nitroimidazole antibiotic, for the treatment of bacterial vaginosis (BV) in nonpregnant women. This preparation of metronidazole offers a convenient single-dose treatment for BV that is packaged in a pre-filled disposable applicator.
Ecallantide for SC injection
In April 2014, the FDA approved ecallantide, a peptide inhibitor of plasma kallikrein, for the treatment of acute hereditary angioedema (HAE) attacks. This drug is the first and only subcutaneous therapy available to treat acute attacks of HAE in patients ≥12 years of age, and is also the only therapy that is not purified from human plasma that has been approved to treat this patient population.
Dalbavancin for IV injection
In May 2014, the FDA approved dalbavancin, a novel secondgeneration lipoglycopeptide antibiotic, 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. To reduce the development of drugresistant bacteria and maintain efficacy, use should be limited to the treatment of infections that are proven or strongly suspected to be caused by susceptible bacteria. Clinical trials showed that dalbavancin was as effective as vancomycin. Dalvance™ is the first drug designated as a Qualified Infectious Disease Product (QIDP) to receive FDA approval.
Taliglucerase alfa for IV injection
In May 2014, this enzyme replacement therapy (ERT) was approved by both Health Canada and The Australian Therapeutic Goods Administration (TGA) for the long-term treatment of adults with a confirmed diagnosis of Type 1 (non-neuropathic) Gaucher disease. It is the first approved plant cell-expressed drug that is derived from a proprietary manufacturing system (ProCellEx®, Protalix Biotherapeutics), using genetically engineered carrot cells.
Efinaconazole 10% topical solution
In June 2014, the FDA approved efinaconazole 10% topical solution for the treatment of mild to moderate onychomycosis. It is the first topical triazole antifungal agent developed for distal lateral subungual onychomycosis (DLSO). The product is applied daily to the nail with a novel bottle that has a built-in flow-through brush applicator.
In April 2014, the European Commission granted marketing authorization to this quadrivalent human papillomavirus (HPV) vaccine (Gardasil®, Sanofi Pasteur) for a 2-dose schedule at 0 and 6 months in children aged 9 to 13 years. This decision is based on data demonstrating that 2 doses elicited an immune response in adolescents comparable to that of 3 doses in young women to the four HPV types – 6, 11, 16 and 18.
In April 2014, both the US FDA and Health Canada issued separate safety advisories informing of labeling changes for belimumab (Benlysta™, GlaxoSmithKline) in the treatment of systemic lupus erythematosus to include the risk of progressive multifocal leukoencephalopathy.