TFS Chemicals - Aspire
Pharma Focus America
Sino Biological - Cytokine

Alvotech Releases Latest Information on the Status of Marketing Authorization Applications for AVT02 and AVT04 in the United States

Saturday, January 20, 2024

Alvotech (NASDAQ: ALVO) issued an announcement today stating that the United States Food and Drug Administration (FDA) has completed its review of Alvotech's production facilities in Reykjavík, which commenced on January 10th. The inspection resulted in a single comment from the inspectors, and Alvotech plans to submit a response to the FDA addressing this comment in the coming days.

Róbert Wessman, Chairman and CEO of Alvotech, expressed confidence in addressing the comment swiftly, mentioning, "We believe it will be a straightforward response to this single comment, and we are committed to providing the necessary information to the FDA at the earliest."

In light of the review's outcome, Alvotech anticipates meeting the conditions for marketing authorization in the United States for AVT02 by no later than February 24th and for AVT04 by no later than April 16th.

patheon - Mastering API production at every scaleWorld Vaccine Congress Europe 2024World Orphan Drug Congress 2024Future Labs Live USA 2024patheon - Revolutionizing PharmaHealthcare CNO SummitHealthcare CMO Summit