FDA Grant Symbicort Six Months Exclusivity
News Jan 30, 2017
AstraZeneca announced that on 25 January 2017 the US Food and Drug Administration (FDA) granted six months of paediatric exclusivity for Symbicort (budesonide/formoterol) Inhalation Aerosol.
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 US to treat asthma in patients 12 years and older and for the maintenance treatment of Chronic Obstructive Pulmonary Disease (COPD) in adults.
This article has been republished from materials provided by Astra Zeneca. Note: material may have been edited for length and content. For further information, please contact the cited source.
Children With Congenital Zika Virus Infection Face Serious Challenges as They AgeNews
The report from the CDC is the first to describe the health and developmental effects of congenital Zika virus infection in children with microcephaly through 2 years of age.READ MORE
British Pharmacological Society’s Drug Discovery of the Year 2018 AnnouncedNews
A new medicine used to treat an ultra-rare inherited disorder which leaves babies without a fully functioning immune system has been named the British Pharmacological Society’s Drug Discovery of the Year 2018.READ MORE