BLA Resubmission to be Filed Today
NEWPORT BEACH, CA, USA I October 06, 2022 I Hugel America, Inc. (Hugel Aesthetics) announced today that it has resubmitted its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for letibotulinumtoxinA for Injection for the treatment of moderate to severe glabellar lines.
The resubmission follows the receipt of a Complete Response Letter (CRL) from the FDA in March 2022, which required additional data to complete the review of the BLA. Deficiencies cited by the FDA in the CRL were primarily associated with chemistry, manufacturing, controls (CMC), and general updates.
Jim Hartman, President and COO commented, “Today we are resubmitting our BLA and look forward to receiving notice next month of the FDA’s acceptance of our resubmission and the assignment of a new FDA action date.”
About Hugel Aesthetics
Hugel Aesthetics is a division of the global medical aesthetics leader, Hugel, Inc., focused on commercializing a synergistic aesthetic portfolio in the United States, Canada, and Australia.
Hugel Aesthetics is dedicated to making aesthetics more attainable for all. For more information, visit: www.hugel-aesthetics.com
SOURCE: Hugel
Post Views: 34
BLA Resubmission to be Filed Today
NEWPORT BEACH, CA, USA I October 06, 2022 I Hugel America, Inc. (Hugel Aesthetics) announced today that it has resubmitted its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for letibotulinumtoxinA for Injection for the treatment of moderate to severe glabellar lines.
The resubmission follows the receipt of a Complete Response Letter (CRL) from the FDA in March 2022, which required additional data to complete the review of the BLA. Deficiencies cited by the FDA in the CRL were primarily associated with chemistry, manufacturing, controls (CMC), and general updates.
Jim Hartman, President and COO commented, “Today we are resubmitting our BLA and look forward to receiving notice next month of the FDA’s acceptance of our resubmission and the assignment of a new FDA action date.”
About Hugel Aesthetics
Hugel Aesthetics is a division of the global medical aesthetics leader, Hugel, Inc., focused on commercializing a synergistic aesthetic portfolio in the United States, Canada, and Australia.
Hugel Aesthetics is dedicated to making aesthetics more attainable for all. For more information, visit: www.hugel-aesthetics.com
SOURCE: Hugel
Post Views: 34
