Health Canada approval for Wakik (pitolisant hydrochloride tablets) for the treatment of excessive daytime sleepiness (EDS) or cataplexy in pediatric patients
Paladin Labs Inc., a subsidiary of Endo International plc announced Health Canada’s approval of Wakik (pitolisant hydrochloride tablets) for the treatment of excessive daytime sleepiness (EDS) or cataplexy in pediatric patients aged 6 years and older and weighing at least 30 kg with narcolepsy.
“Health Canada’s approval of Wakik for appropriate pediatric patients with narcolepsy marks a significant milestone. We are proud to offer an option for Canadians struggling with narcolepsy’s debilitating symptoms, EDS and cataplexy, and potentially empowering caregivers to help manage their condition,” said Livio Di Francesco, Vice President & General Manager of Paladin Labs Inc. “Paladin Labs is committed to offering innovative treatment options to help support the unmet medical needs of Canadian patients.”
In 2018, Endo Ventures Limited, a subsidiary of Endo International plc, entered into an agreement with Bioprojet SCR to register, commercialize, and distribute pitolisant hydrochloride on an exclusive basis in Canada. Paladin Labs Inc., an operating company of Endo, is commercializing pitolisant hydrochloride in Canada.
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