Mylan launches generic Wixela in US at 70-percent discount to GlaxoSmithKline's Advair

Mylan on Tuesday announced the US commercial launch of Wixela Inhub (fluticasone/salmeterol), the first generic version of GlaxoSmithKline's therapy Advair Diskus approved by the FDA, at a 70-percent discount to the wholesale cost of the originator product. The company noted that the prices for the three dosage strengths of the therapy also represent a 67-percent discount to that for GlaxoSmithKline's authorised generic of Advair.  

Mylan chief commercial officer Tony Mauro remarked "we trust that by launching Wixela Inhub at a significantly discounted list price, we will demonstrate the savings that generics can deliver for patients through reduced out-of-pocket costs, as well as the US healthcare system overall."  

Approval of the therapy came after the FDA previously issued a complete response letter to Mylan's initial filing. The drugmaker later said it was anticipating a second complete response letter for its resubmission after the FDA told the company it had identified "minor deficiencies, although Mylan subsequently hinted last October that approval was "imminent." 

Approval of the therapy also came after FDA Commissioner Scott Gottlieb unveiled a number of initiatives seeking to hasten the approval of complex generics. 

To read more Top Story articles, click here.