FDA to reject approval of Mylan's generic version of GlaxoSmithKline's Advair

Mylan on Wednesday said it expects to receive a complete response letter from the FDA concerning a filing seeking approval of a generic version of GlaxoSmithKline's Advair Diskus (fluticasone/salmeterol). The drugmaker stated that the FDA has identified "minor deficiencies" to be relayed in a complete response letter on June 27.  

Mylan did not provide information regarding the nature of the deficiencies but indicated that it will review the letter before determining any potential impact on its 2018 financial outlook. 

Mylan's submission of a generic version of Advair Diskus was initially accepted by the FDA in 2016 but the agency subsequently declined to approve the therapy last year. Mylan has not divulged the reasons for the rejection.  

FirstWord Reports: Providing insight, analysis and expert opinion on important Pharma trends and challenging issues <Click here>

Earlier this year, GlaxoSmithKline predicted that it might avoid generic competition for Advair this year after the FDA issued a complete response letter to Novartis regarding its filing seeking approval of a generic version of the drug. In March, the FDA also affirmed its prior decision to reject Hikma Pharmaceuticals' submission seeking clearance of a generic version of Advair and directed the company to conduct an additional clinical study. Hikma partners with Vectura, using the latter's dry powder inhaler and formulation technology.

GlaxoSmithKline recorded about 1.6 billion pounds ($2.1 billion) in revenue for Advair in the US last year. In May, the company revealed plans to increase sales of new respiratory products including Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) to offset revenue losses for Advair. 

To read more Top Story articles, click here.