FDA sends Pozen a second Complete Response Letter regarding Yosprala manufacturing issues

18 December 2014

US pharma company Pozen (Nasdaq: POZN) has received a second complete response letter from the US Food and Drug Administration for Yosprala (aspirin/omeprazole delayed release tablets).

A complete response letter is issued by the FDA when the review of the file is completed and questions remain that mean the regulator cannot approve a New Drug Application in its current form.

Foreign manufacturing issues

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