Hikma has temporarily paused the launch of its generic version of GlaxoSmithKline’s Advair Diskus.
Following the Food and Drug Administration’s approval of Hikma’s ANDA for generic Advair Diskus in December 2020, Hikma has submitted an amendment to its application to the FDA.
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 said.
Hikma also said that it will work closely with the FDA in its review and will commence distribution of the product once the review has been completed.