Hikma temporarily suspends launch of generic Advair Diskus

Hikma Pharmaceuticals said on Friday that it had temporarily paused the launch of its generic version of GlaxoSmithKline's asthma treatment, Advair Diskus.

The US Food and Drug Administration approved Hikma's Abbreviated New Drug Application (ANDA) for generic Advair Diskus in December 2020. However, the company has since submitted an amendment to the application, which reflects enhanced packaging controls to meet new industry standards adopted since the initial submission of its ANDA application.

HIkma said the amendment will be classified as a Prior Approval Supplement and will not affect the approved status of the company’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," it said.