{"id":49293,"date":"2022-10-06T19:01:55","date_gmt":"2022-10-06T17:01:55","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/hugel-aesthetics-resubmits-biologics-license-application-for-letibotulinumtoxina-for-injection-for-glabellar-lines-to-the-fda\/"},"modified":"2022-10-06T19:01:55","modified_gmt":"2022-10-06T17:01:55","slug":"hugel-aesthetics-resubmits-biologics-license-application-for-letibotulinumtoxina-for-injection-for-glabellar-lines-to-the-fda","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/hugel-aesthetics-resubmits-biologics-license-application-for-letibotulinumtoxina-for-injection-for-glabellar-lines-to-the-fda\/","title":{"rendered":"Hugel Aesthetics Resubmits Biologics License Application for LetibotulinumtoxinA for Injection for Glabellar Lines to the FDA"},"content":{"rendered":"
\n

\nBLA Resubmission to be Filed Today<\/i>\n<\/p>\n

NEWPORT BEACH, Calif.–(BUSINESS WIRE)–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.\n<\/p>\n

\nThe 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.\n<\/p>\n

\nJim Hartman, President and COO commented, \u201cToday we are resubmitting our BLA and look forward to receiving notice next month of the FDA\u2019s acceptance of our resubmission and the assignment of a new FDA action date.\u201d\n<\/p>\n

\nAbout Hugel Aesthetics\n<\/p>\n

\nHugel 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.\n<\/p>\n

\nHugel Aesthetics is dedicated to making aesthetics more attainable for all. For more information, visit: www.hugel-aesthetics.com<\/a>\n<\/p>\n

Contacts<\/b> <\/p>\n

\nKayleigh Adam, <\/b>Alison Brod Marketing Communications, kayleigh@abmc-us.com<\/a>\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

BLA Resubmission to be Filed Today NEWPORT BEACH, Calif.–(BUSINESS WIRE)–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 … [Read more…]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-49293","6":"format-standard","7":"category-industry"},"yoast_head":"\nHugel Aesthetics Resubmits Biologics License Application for LetibotulinumtoxinA for Injection for Glabellar Lines to the FDA - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/hugel-aesthetics-resubmits-biologics-license-application-for-letibotulinumtoxina-for-injection-for-glabellar-lines-to-the-fda\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Hugel Aesthetics Resubmits Biologics License Application for LetibotulinumtoxinA for Injection for Glabellar Lines to the FDA - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"BLA Resubmission to be Filed Today NEWPORT BEACH, Calif.–(BUSINESS WIRE)–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 ... 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