FDA Delivers CRL for Longer Dosage Intervals in Aflibercept for DME, Wet AMD

FDA issues alerts on certain catheters produced by BD, Conavi

The Food and Drug Administration has issued alerts for issues with certain catheters made by BD and Conavi. BD identified an increase in material fatigue leaks associated with certain PowerPICC Intravascular Catheters. The FDA sent a letter to affected consumers recommending unused catheters be removed from where they are used or sold, and in-use catheters have updated instructions.Conavi reported an incident where the sheath of its Novasight Hy…

FDA Denies Regeneron's BLA for Extended Dosing Intervals for Eylea HD

Regeneron announced that the FDA has issued a complete response letter (CRL) regarding the supplemental Biologics License Application (sBLA) for the addition of extended dosing intervals (up to every 24 weeks) for Eylea HD (aflibercept) Injection 8 mg across all approved indications. According to Regeneron, the CRL did not identify any issues with the safety or efficacy of Eylea HD in its approved indications and dosing regimens. "The FDA did no…

FDA issues CRL for Regeneron's aflibercept 8 mg (Eylea HD) sBLA

The FDA did not agree with a supplemental Biologics License Application for the addition of extended dosing intervals of up to 24 weeks across currently-approved indications.

FDA Delivers CRL for Longer Dosage Intervals in Aflibercept for DME, Wet AMD

The complete response letter (CRL) specifies that the current dosage duration of aflibercept is still safe but extending the duration is not approved.

Regeneron announces FDA issues CRL for aflibercept 8 mg (Eylea HD) sBLA

The FDA did not agree with a supplemental Biologics License Application for the addition of extended dosing intervals of up to 24 weeks across currently-approved indications.