MedWatch

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.

Already a subscriber? Log in.

Read the whole article

Get access for 14 days for free.
No credit card is needed, and you will not be automatically signed up for a paid subscription after the free trial.

  • Access all locked articles
  • Receive our daily newsletters
  • Access our app
An error has occured. Please try again later.

Get full access for you and your coworkers.

Start a free company trial today

More from MedWatch

Further reading

Related articles

Latest news

See all jobs