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Hikma Suspends Roll-Out Of Advair Rival

Follows Amendment Filed With US FDA Over Packaging Update

 
• By Dave Wallace

Hikma has temporarily stopped the roll-out of its rival to Advair Diskus in the US after it filed an amendment to its ANDA over packaging controls.

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Hikma has paused the launch of its Advair Diskus rival • Source: Shutterstock

Hikma has temporarily suspended the roll-out of its generic version of GlaxoSmithKline’s Advair Diskus (fluticasone/salmeterol) in the US, just a month after the product was approved and launched. The pause is linked with an amendment to the firm’s abbreviated new drug application over packaging controls.

Announcing that it had “temporarily paused” the launch of its generic, Hikma explained that “following the US Food and Drug Administration’s approval of Hikma’s ANDA for generic Advair Diskus in December 2020, Hikma has submitted to the FDA an amendment to its application

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