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Hikma Addresses Advair Issues In US

Responds To All Outstanding Questions In The FDA’s CRL

 
• By Dave Wallace

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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Hikma says it has ticked off every question posed by the FDA’s Complete Response Letter • Source: Shutterstock

Hikma says it has now addressed all outstanding questions from the US Food and Drug Administration over the firm’s application for a generic version of GlaxoSmithKline’s Advair Diskus (fluticasone/salmeterol) blockbuster respiratory brand.

Having in May 2017 received an FDA complete response letter indicating that their abbreviated new drug application was not ready for approval, in early 2018 Hikma and its development partner Vectura were told by the agency that they would have to complete an additional clinical endpoint study following a dispute-resolution process with the FDA

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