BLESS

Hugel resubmits BLA for its botulinum toxin, Botulax to the U.S. FDA

Retrieved on: 
Saturday, October 8, 2022
CRL, Allergan, BLESS, Endpoint security, Marketing, TOP, KRW, CEO, BLA, FDA, Dietary supplement, Pharmaceutical industry, Hugel & Fils

Hugel had received a Complete Response Letter (CRL) from the U.S. FDA last March after submitting the BLA for Botulax (50 and 100 units) in order to advance into the U.S. market in March of last year.

Key Points: 
  • Hugel had received a Complete Response Letter (CRL) from the U.S. FDA last March after submitting the BLA for Botulax (50 and 100 units) in order to advance into the U.S. market in March of last year.
  • The company sent supplemental documents and data based on requests set out in the CRL and resubmitted the BLA to the U.S. FDA.
  • Hugel America, a U.S. subsidiary which will be in charge of Hugel's U.S. sales and marketing of Botulax.
  • It submitted a BLA in April of last year, and undertook on-site due diligence at its Geodu factory in August.

Hugel resubmits BLA for its botulinum toxin, Botulax to the U.S. FDA

Retrieved on: 
Friday, October 7, 2022
CRL, Allergan, BLESS, Endpoint security, Marketing, TOP, KRW, CEO, BLA, FDA, Dietary supplement, Pharmaceutical industry, Hugel & Fils

Hugel had received a Complete Response Letter (CRL) from the U.S. FDA last March after submitting the BLA for Botulax (50 and 100 units) in order to advance into the U.S. market in March of last year.

Key Points: 
  • Hugel had received a Complete Response Letter (CRL) from the U.S. FDA last March after submitting the BLA for Botulax (50 and 100 units) in order to advance into the U.S. market in March of last year.
  • The company sent supplemental documents and data based on requests set out in the CRL and resubmitted the BLA to the U.S. FDA.
  • Hugel America, a U.S. subsidiary which will be in charge of Hugel's U.S. sales and marketing of Botulax.
  • It submitted a BLA in April of last year, and undertook on-site due diligence at its Geodu factory in August.

Hugel resubmits BLA for its botulinum toxin, Botulax to the U.S. FDA

Retrieved on: 
Friday, October 7, 2022
CRL, Allergan, BLESS, Endpoint security, Multimedia, Marketing, TOP, KRW, CEO, BLA, FDA, View, Dietary supplement, Pharmaceutical industry, Hugel & Fils

SEOUL, South Korea, Oct. 7, 2022 /PRNewswire/ -- Hugel (CEO Jihoon Sohn), a global total medical aesthetics company, announced that it resubmitted the BLA for its botulinum toxin called Botulax on October 6th (local time), for the indication of glabellar lines to the U.S. FDA.

Key Points: 
  • SEOUL, South Korea, Oct. 7, 2022 /PRNewswire/ -- Hugel (CEO Jihoon Sohn), a global total medical aesthetics company, announced that it resubmitted the BLA for its botulinum toxin called Botulax on October 6th (local time), for the indication of glabellar lines to the U.S. FDA.
  • Hugel had received a Complete Response Letter (CRL) from the U.S. FDA last March after submitting the BLA for Botulax (50 and 100 units) in order to advance into the U.S. market in March of last year.
  • The company sent supplemental documents and data based on requests set out in the CRL and resubmitted the BLA to the U.S. FDA.
  • Hugel America, a U.S. subsidiary which will be in charge of Hugel's U.S. sales and marketing of Botulax.

Hugel resubmits BLA for its botulinum toxin, Botulax to the U.S. FDA

Retrieved on: 
Friday, October 7, 2022
CRL, Allergan, BLESS, Endpoint security, Multimedia, Marketing, TOP, KRW, CEO, BLA, FDA, View, Dietary supplement, Pharmaceutical industry, Hugel & Fils

SEOUL, South Korea, Oct. 7, 2022 /PRNewswire/ -- Hugel (CEO Jihoon Sohn), a global total medical aesthetics company, announced that it resubmitted the BLA for its botulinum toxin called Botulax on October 6th (local time), for the indication of glabellar lines to the U.S. FDA.

Key Points: 
  • SEOUL, South Korea, Oct. 7, 2022 /PRNewswire/ -- Hugel (CEO Jihoon Sohn), a global total medical aesthetics company, announced that it resubmitted the BLA for its botulinum toxin called Botulax on October 6th (local time), for the indication of glabellar lines to the U.S. FDA.
  • Hugel had received a Complete Response Letter (CRL) from the U.S. FDA last March after submitting the BLA for Botulax (50 and 100 units) in order to advance into the U.S. market in March of last year.
  • The company sent supplemental documents and data based on requests set out in the CRL and resubmitted the BLA to the U.S. FDA.
  • Hugel America, a U.S. subsidiary which will be in charge of Hugel's U.S. sales and marketing of Botulax.

Hugel Aesthetics to Present Data from Phase 3 Clinical Trial At 2022 American Society of Dermatologic Surgery Annual Meeting

Retrieved on: 
Wednesday, October 5, 2022
General Health, Health, Clinical Trials, Other Health, VAS, Society, Quality of life, ASDS, Review, BLESS, View, Safety, Pharmaceutical industry

Hugel America, Inc. (Hugel Aesthetics) announced today that the company will have an oral presentation at the American Society for Dermatologic Surgery (ASDS) annual meeting (Oct. 6-10, 2022 in Denver, CO) highlighting data from its phase 3 clinical trial, BLESS III, assessing the efficacy of letibotulinumtoxinA in improving the psychosocial health-related quality of life (QoL) of subjects with moderate to severe glabellar lines.

Key Points: 
  • Hugel America, Inc. (Hugel Aesthetics) announced today that the company will have an oral presentation at the American Society for Dermatologic Surgery (ASDS) annual meeting (Oct. 6-10, 2022 in Denver, CO) highlighting data from its phase 3 clinical trial, BLESS III, assessing the efficacy of letibotulinumtoxinA in improving the psychosocial health-related quality of life (QoL) of subjects with moderate to severe glabellar lines.
  • Hyperfunctional glabellar frown lines can transmit facial miscues that adversely affect emotional communication and facial attractiveness, increase perceptions of age, and diminish self-esteem.
  • The Hugel Aesthetics application for letibotulinumtoxinA for the treatment of glabellar lines is currently under review by the U.S. FDA.
  • Hugel Aesthetics is dedicated to making aesthetics more attainable for all.

New Published Data Supports the Safety and Efficacy of LetibotulinumtoxinA for the Treatment of Glabellar Lines

Retrieved on: 
Wednesday, July 27, 2022
FDA, Surgery, Hospitals, Health, Clinical Trials, BLESS, Female, Male, FWS, Aesthetic Surgery Journal, Aesthetics, Clinical trial, Week, Trial of the century, Pharmaceutical industry

The published data comes as Hugel is accelerating its efforts towards becoming a leading global medical aesthetics company.

Key Points: 
  • The published data comes as Hugel is accelerating its efforts towards becoming a leading global medical aesthetics company.
  • LetibotulinumtoxinA safety and efficacy were evaluated in a randomized, double-blind, placebo-controlled, multicenter phase 3 clinical trial of subjects with moderate-to-severe glabellar lines.
  • Efficacy and Safety of Letibotulinum Toxin A in the Treatment of Glabellar Lines: A Randomized, Double-blind, Multicenter, Placebo-controlled Phase 3 Study.
  • The Hugel Aesthetics application for letibotulinumtoxinA for the treatment of glabellar lines is currently under review by the U.S. Food and Drug Administration.