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Hikma Resumes Launch Of Advair Rival

Follows FDA Approval Of ANDA Amendment That Forced Pause

 
• By Dave Wallace

Hikma has restarted launch activities for its generic version of GSK’s Advair respiratory blockbuster in the US, after the FDA gave the go-ahead following approval of an ANDA amendment.

Restart Wooden Blocks
Hikma has restarted launch activities for its generic version of Advair • Source: Alamy

Hikma “will immediately resume launch activities” for its generic version of GlaxoSmithKline’s Advair Diskus (fluticasone/salmeterol) in the US, after the Food and Drug Administration approved a necessary amendment to the firm’s abbreviated new drug application that had forced it to put launch plans on hold in early 2021.

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