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 as Effective as FDA-Approved Drugs Against Life-Threatening InfectionsNews
Purdue University researchers have identified a new compound that in preliminary testing has shown itself to be as effective as antibiotics approved by the Food and Drug Administration to treat life-threatening infections while also appearing to be less susceptible to bacterial resistance.READ MORE
Chemists Design 'Mini-ecosystems' to Test Drug FunctionNews
Scripps Research scientists have solved a major problem in chemistry and drug development by using droplet-sized 'miniecosystems' to quickly see if a molecule can function as a potential therapeutic.READ MORE
Targeting the Engine Room of the Cancer CellNews
Researchers at Columbia University Irving Medical Center (CUIMC) have developed a highly innovative computational framework that can support personalized cancer treatment by matching individual tumors with the drugs or drug combinations that are most likely to kill them.READ MORE
Comments | 0 ADD COMMENT
10th Annual Congress on Drug Formulation & Analytical Techniques
Sep 03 - Sep 04, 2018