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Knight and TherapeuticsMD Announce Filing of New Drug Submission for Joyesta™ in Canada
MONTREAL & BOCA RATON, Fla.--(BUSINESS WIRE)-- Knight Therapeutics Inc. (TSX: GUD) (“Knight”) and TherapeuticsMD, Inc. (NASDAQ: TXMD) (“TherapeuticsMD”)
About this update from Therapeuticsmd, Inc.
[{"type":"text","content":" MONTREAL & BOCA RATON, Fla.--(BUSINESS WIRE)--\nKnight Therapeutics Inc. (TSX: GUD) (“Knight”) and TherapeuticsMD, Inc. (NASDAQ: TXMD) (“TherapeuticsMD”) announced today that Knight's New Drug Submission (NDS) for Joyesta™ has been accepted for review by Health Canada. Joyesta, licensed from TherapeuticsMD, is an applicator-free estradiol softgel vaginal capsule for the treatment of postmenopausal symptoms of vulvar and vaginal atrophy due to estrogen deficiency. Joyesta is marketed as IMVEXXY® (estradiol vaginal inserts) by TherapeuticsMD in the U.S., for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause.\nThis press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20191030005762/en/\n\n“We look forward to bringing Joyesta to Canadian patients,” said Jonathan Ross Goodman, Chief Executive Officer of Knight. “With over 50% of postmenopausal women suffering from these symptoms, we are excited about the potential of Joyesta to address their needs.”\n\n\n“We are pleased to partner with the team at Knight as they work to bring this meaningful product to Canadian women,” said Robert Finizio, Chief Executive Officer of TherapeuticsMD.\n\n\nKnight and TherapeuticsMD signed an agreement in July 2018 with TherapeuticsMD granting Knight the exclusive Canadian commercialization rights to Joyesta and BIJUVA® (estradiol and progesterone) capsules.\n\n\nAbout Joyesta™ \n\n\nJoyesta was developed and approved in the U.S. as IMVEXXY® (estradiol vaginal inserts) for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. IMVEXXY is the only product in its therapeutic class to offer a 4 mcg and a 10 mcg dose, the 4 mcg represents the lowest U.S. Food and Drug Administration-approved dose of vaginal estradiol.\n\n\nPlease see U.S. Full Prescribing Information for IMVEXXY, including BOXED WARNING for endometrial cancer, cardiovascular disorders, breast cancer, and probable dementia, available at www.imvexxy.com/pi.pdf.\n\n\nPlease see U.S. Full Prescribing Information for BIJUVA, including BOXED WARNING for cardiovascular disorders, breast cancer, endometrial cancer and probable dementia, available at https://www.bijuva.com/pi.pdf.\n\n\nAbout Knight Therapeutics Inc. \n\n\nKnight Therapeutics I...