Time to sort Hikma's hiccup with Advair Diskus generic gives GSK more breathing space

12 March 2018

Hikma Pharmaceuticals (LSE: HIK) closed 2% down in London trading on Monday at £8.80 as markets digested the amount of time it will take to resubmit data for its abbreviated new drug application (ANDA) for a generic version of Advair/Seretide Diskus (fluticasone/salmeterol).

The company received a complete response letter (CRL) from the US Food and Drug Administration (FDA) in relation to the ANDA in May 2017. In the following months, the firm worked with the agency to address and clarify the majority of the questions raised.

However, an issue regarding the clinical endpoint study remained outstanding, prompting Hikma to engage in the FDA’s dispute resolution process.

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