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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).
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Protalix receives CRL for Gaucher disease treatment
KARMIEL, Israel — The Food and Drug Administration has declined to approve a biologic treatment for a rare genetic disorder by Israeli drug maker Protalix Biotherapeutics, Protalix said Friday.
The company said the FDA issued a complete response letter for its application for taliglucerase alfa, a treatment for Gaucher disease. The FDA issues a CRL when it has finished reviewing a regulatory application, but questions remain that preclude final approval.