London, 15 January 2021 – Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company, announces that it has temporarily paused the launch of its generic version of GlaxoSmithKline’s Advair Diskus® .
15 January 2021
Inside information, Product, Press Release
Following the US FDA’s approval of Hikma’s Abbreviated New Drug Application (ANDA) for generic Advair Diskus® in December 2020, Hikma has submitted to the US FDA an amendment to its application. The amendment reflects enhanced packaging controls to meet new industry standards adopted since the initial submission of its ANDA application. This amendment will be classified as a Prior Approval Supplement and will not affect the approved status of Hikma’s ANDA for generic Advair Diskus®.
Hikma will work closely with the FDA in its review and will commence distribution of the product once the review has been completed.