• Regulatory NewsRegulatory News

    Mylan Wins FDA Approval for First Advair Generic

    The US Food and Drug Administration (FDA) late Wednesday approved the first generic version of GlaxoSmithKline’s Advair Diskus (fluticasone propionate and salmeterol inhalation powder) for the twice-daily treatment of asthma in patients aged four years and older and maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). Generating almost $80 billion in sales since its initial launch, competi...
  • Regulatory NewsRegulatory News

    Gottlieb: More Guidance on Complex Generics Coming

    The US Food and Drug Administration’s (FDA) difficulties in approving generic versions of complex products were front and center in Commissioner Scott Gottlieb’s comments at FDA’s Generic Drug Science Day on Tuesday. Complex generic drugs – often declared complex because of their unique formulations (such as ophthalmic suspensions like with Allergan’s Restasis (cyclosporine), gels or others like Janssen’s chemotherapy Doxil ), active ingredients (including peptides...