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Motif Bio skin infection treatment accepted for filing by FDA

Tuesday, 14th August 2018
Motif Bio said the US Food & Drug Administration had accepted for filing its new drug application for an antibiotic that treats acute bacterial skin and skin structure infections.

The development meant that the FDE had determined that the application, for the treatment called iclaprim, was sufficiently complete to perform a substantive review.

The application had been granted priority review and the FDA had set a target decision date of February 13, 2019, Motif Bio said.

'We believe that, if approved, iclaprim could be an important new treatment option for patients with serious skin infections,' chief executive Graham Lumsden said.

'We look forward to working closely with the FDA as we move through the review process with the goal of bringing iclaprim to patients as quickly as possible.'




Story provided by StockMarketWire.com

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