Once again, Shire seeks FDA approval for Firazyr
DUBLIN — British drug maker Shire again is trying to win approval for a hereditary angioedema drug that the Food and Drug Administration had previously declined to approve.
Shire said Monday that it had submitted a response to the "not approvable letter" the FDA sent to German subsidiary Jerini AG in April 2008 for the drug Firazyr (icatibant).
The new application includes data that the agency had requested regarding the drug’s safety and efficacy. Approvable and not approvable letters sent by the FDA when it declines to approve a drug are now known as complete response letters.