Posted by Michael Wonder on 11 May 2017
Mylan disagrees with FDA over generic Advair delay
10 May 2017 - Generic drug maker Mylan on Wednesday said it disagrees with the reasoning behind the U.S. FDA's decision not to approve its generic for GlaxoSmithKline's blockbuster Advair in March.
Mylan President Rajiv Malik said the FDA was asking it to comply with standards set out in draft guidance the agency issued, but that it believes it is not required to do so. An FDA spokeswoman declined to comment, saying she was prohibited by law from discussing a pending application.
Mylan made the comments while reporting first-quarter earnings, in which it flagged declining sales for emergency allergy treatment EpiPen but said it will still meet previously announced earnings targets for the year.
