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.
Compound Offers Pain-relief of Opioids Without Addictive PropertiesNews
Researchers have engineered a new compound that animal tests suggest could offer the pain-relieving properties of opioids such as morphine and oxycodone without the risk of addiction.READ MORE
E. Coli’s Internal Bomb Offers Chink In ArmourNews
Bacteria's internal bomb, the so-called toxin-antitoxin (TA) system that is part of the normal bacterial makeup, may be triggered to make bacteria turn on themselves, providing a valuable target for novel antimicrobial approaches in drug design.READ MORE