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Hikma fails to secure US approval for generic asthma medicine

Hikma Pharmaceuticals PLC was unable to convince the U.S. Food and Drug Administration to approve its generic asthma medicine.

The London-based drugmaker was looking to market a generic version of GlaxoSmithKline PLC's blockbuster asthma treatment, Advair Diskus, which generated £3.13 billion in full-year 2017 global revenues, including £1.61 billion from the U.S.

The U.S. regulator had rejected Hikma's application in May 2017, citing the need for further information. The company appealed the decision in August 2017.

Having concluded the dispute resolution process, the FDA upheld its original decision and has now asked the company to complete an additional clinical study which Hikma expects to undertake in the near future.

Results from the study will be submitted in 2019 in support of regulatory approval.