"Bad luck" delayed Leo Pharma's prize candidate for eight months
When the FDA tightened up requirements for medical devices midway through evaluating Leo Pharma's tralokinumab, the dermatology company scrambled to collect data on the pre-filled injection pen used to administer the eczema treatment.
by ulrich quistgaard, translated by catherine brett
Sudden and unexpected requirements from the FDA for more data on the protective cap for the syringe used to inject Leo Pharma's eczema treatment meant the product was first launched in the US at Christmas -- more than eight months later than expected.
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