Advair Diskus Fda Approval

The fda had issued a minor crl in response to the anda in september 2020.

Advair diskus fda approval. A previous crl had been issued in may 2017 and in march 2018 hikma said that the fda had asked for an additional clinical trial. Hikma pharmaceuticals announced that the fda has approved 100 mcg 50 mcg and 250 mcg 50 mcg doses of the company s fluticasone propionate salmeterol dpi vr315 a generic version of advair diskus and that the company has launched the inhaler in the us. Hikma worked with vectura group a uk based provider of innovative inhaler drug delivery solutions to develop the proprietary dry powder inhaler and.

Advair diskus fluticasone propionate and salmeterol xinafoate inhalation powder company. Food and drug administration today approved the first generic of advair diskus fluticasone propionate and salmeterol inhalation powder for the twice daily treatment of asthma in patients.