The US Food and Drug Administration (FDA) has told Mylan it will issue a complete response letter (CRL) next week in response to its proposed generic version of GlaxoSmithKline's (GSK) asthma drug.
Advair Diskus is designed to help improve lung function in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis, emphysema, or both.
According to the generics manufacturer, the “FDA has identified minor deficiencies to be relayed on a complete response letter (CRL) on June 27, 2018.”
However according to Mylan, “because our abbreviated new drug application has received a priority designation, our approval could be received prior to the standard 90-day time period following the date of our response to the CRL.”
“Upon receipt of the official CRL, we will determine what, if any, impact that it could have on our full year 2018 outlook,” the firm said in a statement.