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FDA issues complete response letter to Leo Pharma's tralokinumab

Leo Pharma's plans to soon launch dermatitis drug tralokinumab in the US were halted on Thursday, since the FDA has rejected the firm's application for marketing authorization and asks for more data on the injection pen that the drug is packaged in.

Photo: Leo Pharma / PR

Less than a week after the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) approved Leo Pharma's drug tralokinumab, the US Food and Drug Administration (FDA) has arrived at the opposite conclusion in the form of a complete response letter.

In the letter, the FDA calls for further data concerning the device component of tralokinumab that is the injection pen which holds the drug, according to a Leo Pharma press release.

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