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Catalent's Indiana site, linked with Regeneron's high-dose Eylea rejection, dinged with 3 FDA observations


After Regeneron’s high-dose Eylea received a surprising FDA snub, the FDA disclosed cleaning and procedural issues at Catalent, the manufacturer linked with the rejection. | Regeneron’s recent FDA rejection of the high-dose Eylea was attributed to manufacturing issues at Catalent’s Indiana site, the company confirmed. The observations at the site have now been disclosed, revealing problems related to cleaning and sanitization procedures.


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