ADMA - FDA Rejects ADMA's BIVIGAM Drug Substance But Approves Drug Product?
On December 19th, ADMA Biologics (ADMA) received a complete response letter ((CRL)) from the FDA in regards to the Prior Approval Submission ((PAS)) for their intravenous human immunoglobulin ((IVIG)) product, BIVIGAM. This came as surprise to investors due to the company receiving an improved compliance status at their manufacturing facility for BIVIGAM in September. According to the company press release, the CRL mentioned issues with BIVIGAM’s chemistry, manufacturing, and controls ((CMC)) data. However, it did not request supplementary information on compliance status, safety, efficacy or any additional info on third-party contract manufacturers or