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Hikma must add an Advair study

Executive Summary

Hikma has been told by the US Food and Drug Administration (FDA) to complete an additional clinical endpoint study to support its application for a generic version of GlaxoSmithKline’s Advair Diskus (fluticasone/salmeterol), following a dispute-resolution process with the US agency. Hikma had received an FDA complete response letter (CRL) in May 2017 indicating that its abbreviated new drug application (ANDA) was not ready for approval (Generics bulletin, 19 May 2017, page 1). And following disagreement with the FDA over the firm’s clinical endpoint study, Hikma took the matter to the agency’s disputeresolution process (Generics bulletin, 17 November 2017, page 13). “Upholding its original determination”, the FDA has insisted on an additional clinical endpoint study.

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