Pediapharm receives Health Canada approval for rupatadine

21 July 2016 - Pediapharm is very pleased to announce Health Canada's approval of rupatadine fumarate (10 mg tablets and 1 mg/mL oral solution) for the relief of the symptoms associated with seasonal allergic rhinitis, perennial allergic rhinitis and chronic spontaneous urticaria in patients 2 years of age and older.

Rupatadine fumarate is the first prescription anti-histamine being launched over the past decade with all 3 indications, including a formulation for children over 2 years of age. It will be launched in the Canadian anti-histamine market estimated at $130 million. Moreover, it will benefit from 8.5 years of market exclusivity granted by Health Canada's Office of Patented Medicines and Liaison under section C.08.004.1 of the Food and Drug Regulations.

Read Pediapharm press release

Michael Wonder

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Michael Wonder

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Outcome , Medicine , Canada