The UK regulator (MHRA) acted as a referee for the product, which will now be submitted under the Mutual Recognition Procedure for approval in other EU member states.
The marketing application includes all three strengths of fluticasone propionate where the current standard, GlaxoSmithKline’s Flixotide, is available and will be eligible for direct substitution of Glaxo’s product in countries that give approval.
Circassia added the positive regulatory outcome also represented an important validation of its particle-engineering platform in an area where products, and respiratory medicines especially, are difficult to manufacture.
It was the first time a marketing application for a respiratory product of different strengths had been approved using in vitro data only and without a clinical trial, the pharma company added.
Steve Harris, Circassia's chief executive, said: "Achieving this positive outcome is a major milestone for Circassia, marking the favourable conclusion of the company's first ever Marketing Authorisation Application for a product using its particle-engineering technology.
Circassia acquired the technology through its acquisition of Prosonix in June and it has been developed in collaboration with Dutch group Mylan.
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