Le Lézard
Classified in: Health, Science and technology
Subject: Product/Service

Hugel Aesthetics Resubmits Biologics License Application for LetibotulinumtoxinA for Injection for Glabellar Lines to the FDA


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


These press releases may also interest you

at 00:05
Escient Pharmaceuticals, a clinical-stage company advancing novel small molecule therapeutics for the potential treatment of a broad range of neurosensory-inflammatory disorders, today announced the closing of a $120 million Series C financing. The...

at 00:00
Yidu Tech Inc. ("Yidu Tech" or "the Company", together with its subsidiaries and consolidated affiliated entities, "the Group", HKEx: 2158), a leading corporate in China's healthcare intelligence industry, announced the interim results for the six...

27 nov 2022
Diamyd Medical announced today that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on the confirmatory Phase III trial DIAGNODE-3, evaluating the safety and efficacy of the precision medicine and antigen-specific...

27 nov 2022
As the ongoing labour dispute at Kerry's Place enters week two, frontline staff, families and union allies will rally for safety and security so autism support workers can deliver quality services. At issue are staff who are without a single paid...

27 nov 2022
On November 21, 22, and 23, 2022, Crossroads Treatment Center's (CTC/Crossroads) Community Health Program hosted its first-holiday giveaway, consisting of 45 gift baskets, which included a 10-pound turkey and an array of traditional "sides" found at...

27 nov 2022
Everest Medicines (HKEX: 1952.HK), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical...



News published on 6 october 2022 at 12:55 and distributed by: