Hikma filing for generic of Glaxo's Advair Diskus accepted by US FDA

Hikma Pharmaceuticals said on Friday that its abbreviated new drug application for fluticasone propionate and salmeterol inhalation powder has been accepted for filing by the Food and Drug Administration in the US.

The product is the generic version of GlaxoSmithKline's Advair Diskus, which is indicated for the treatment of asthma and the maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD).

It is delivered using Vectura's proprietary dry powder inhaler and formulation technology.

Chief executive officer Said Darwazah said: “We are very pleased to have achieved this important milestone in the development of generic Advair Diskus. With our partner, Vectura, our team has worked closely with the FDA to ensure the quality of the ANDA submission.

“Our interactions with the FDA have helped clarify the requirements for the development of a robust, patient friendly, (AB-rated) substitutable generic product for Advair Diskus. We look forward to bringing to market this very important product for patients."

At 0835 BST, Hikma shares were up 0.4% to 2,086p.