Hikma responds to FDA concerns over 'Advair Diskus' generic

(Sharecast News) - Hikma Pharmaceuticals has submitted its response to deficiencies in its abbreviated new drug application for a generic version of GlaxoSmithKline's 'Advair Diskus', or fluticasone propionate and salmeterol inhalation powder, to the US Food and Drug Administration (FDA), it announced on Wednesday.
The FTSE 100 pharmaceuticals company said that, following receipt of a complete response letter from the FDA, it had initiated a clinical endpoint study in 2018.

That study had now been completed and it, along with other information requested by the FDA, submitted to the FDA for review.

The submission addressed the outstanding questions raised by the FDA in its response letter, Hikma explained.

"Our team has worked extremely hard with Vectura to complete a large and challenging clinical study, which we believe demonstrates the safety and effectiveness of our product, and I am very pleased to have responded to the FDA," said chief executive officer Siggi Olafsson.

"As we continue to develop our pipeline of complex generics, respiratory products are a key strategic focus for Hikma and our generic Advair submission is an important milestone.

"We are confident in our ability to bring a generic version of Advair to the US market, which would enable us to improve patient access to this important medicine."