US pediatric exclusivity for Symbicort

26 January 2017

The US Food and Drug Administration has granted six months of pediatric exclusivity for Symbicort (budesonide/formoterol) Inhalation Aerosol, Anglo-Swedish pharma major AstraZeneca (LSE: AZN) announced this morning.

The FDA’s decision was based on the evaluation of trials conducted in children with asthma aged six up to 12 years in response to a Written Request (a prerequisite for qualifying for paediatric exclusivity under Section 505A of the Federal Food, Drug, and Cosmetic Act). Symbicort is currently approved in the USA to treat asthma in patients 12 years and older and for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adults.

Symbicort was first launched in Sweden in 2000 and has been approved in around 120 countries to treat asthma and/or COPD either as Symbicort Turbuhaler or Symbicort pMDI (pressurized metered-dose inhaler). The drug generated third-quarter 2016 sales of $697 million for the company.

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