Hikma has resumed the launch of generic Advair Diskus following the Food and Drug Administration’s approval of an amendment Hikma submitted to its ANDA in January 2021. The amendment reflected enhanced packaging controls to meet new industry standards adopted since the initial submission of its ANDA.
Hikma will immediately resume launch activities of fluticasone propionate and salmeterol inhalation powder), which is the generic of GlaxoSmithKline's Advair Diskus. The product is available in 100 mcg/50 mcg and 250 mcg/50 mcg dosage strengths.
“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.” Siggi Olafsson, Hikma CEO said. “We are very pleased to improve availability of this critical medicine for patients and healthcare providers in the United States.