Hikma Pharmaceuticals said that the FDA has approved an amendment to the company’s ANDA for its generic version of Advair Diskus fluticasone propionate / salmeterol DPI, and the company has subsequently restarted the launch of the inhaler. The FDA initially approved the ANDA in December 2020, and the company said that it was launching the DPI at that time.
Hikma paused the launch of the DPI in mid-January 2021, announcing that it had submitted an amendment to the ANDA that “reflected enhanced packaging controls to meet new industry standards adopted since the initial submission of its ANDA.” Now the company says that it is resuming the launch following FDA approval of the amendment.
Hikma CEO Siggi Olafsson commented, “We appreciate the FDA’s timely review and approval of our amendment and are now immediately resuming the launch of our high quality, substitutable generic version of Advair Diskus. We are very pleased to improve availability of this critical medicine for patients and healthcare providers in the US.”
Read the Hikma press release.
