In a letter from the FDA to Sunovion dated March 12, 2015, the agency informed the company that all postmarketing requirements and commitments specified after the 2005 approval of the Xopenex HFA levalbuterol MDI have been completed. A labeling change regarding the use of Xopenex HFA in children less than four years old was also approved.
The agency accepted the results of one pediatric study submitted by Sunovion and agreed to waive an additional required pediatric safety study “because this study will not provide any additional safety or efficacy data for Xopenex HFA beyond what has been obtained and included in the product labeling.”
The FDA had initially required two postmarketing studies in children less that four years of age to meet requirements of the Pediatric Research Equity Act (PREA). The study that was submitted was titled “A 4 week safety, efficacy, and tolerability study with Xopenex HFA in children with asthma from birth to less than 4 years of age.” The study that was waived would have been a safety and tolerability study in the same population.
Read the FDA letter.
