Hikma Addresses Advair Issues In US
Responds To All Outstanding Questions In The FDA’s CRL
Hikma has submitted a response to the US FDA addressing all outstanding deficiencies in its application for a generic version of GlaxoSmithKline’s Advair Diskus.
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Mylan is pushing ahead with reforms that include wide-ranging product rationalization in the US, refocusing its commercial resources and cutting development and manufacturing costs. These reforms are intended to run prior to and concurrently with the group’s merger with Pfizer’s Upjohn unit to form Viatris.
Lannett has struck a deal giving it exclusive US distribution rights for 10 years to a generic version of Advair Diskus being developed by China’s Respirent.