LONDON (Alliance News) - Motif Bio PLC said Friday that its flagship antibiotic iclaprim has been granted a designation by the US Food and Drug administration which qualifies it for incentives including priority review, fast-track designation, and eligibility for a five year extension of market exclusivity if approved.
Iclaprim has been granted a qualified infectious diseases product designation for hospital-acquired bacterial pneumonia.
The company has also applied for the product to get the same designation in acute bacterial skin and skin structure infections, and is awaiting confirmation from the FDA on this designation in the next few days, following the completion of an additional administrative step requested by the FDA.
By Hana Stewart-Smith; hanassmith@alliancenews.com; @HanaSSAllNews
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