Schering-Plough Asmanex
Dose counter mechanism for mometasone furoate dry powder inhaler "has not been proven to be accurate or reliable," Jan. 19 FDA 483 inspection report states. Manual counts did not match the numbers displayed by the inhaler device's counter, FDA observed. The counting mechanism also exhibited "jamming" and would not decrement as intended. The once-daily corticosteroid has been "approvable" since October 1999 for treatment of asthma in patients 12 and older. The 483 was released by Public Citizen March 1 (1see related story, p. 6)
More from Archive
Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.
A new pilot aims to take Brazil closer to ‘digital transformation.’
More from Pink Sheet
Last Minute Course Shifts, Focus On Unknowns: What Sponsors Should Learn From Prasad’s Interventions
The once and current CBER director’s justification for his COVID-19 decision stands as a warning of the uncertainty sponsors, particularly those in the vaccine space, may now face at FDA.
Pink Sheet Drug Review Profile feature listing FDA staff who conducted the reviews of Novavax and Moderna's post-pandemic COVID-19 vaccines
Business Group on Health annual employer survey highlights fast-growing Rx costs, led by the GLP-1 drugs, and payer strategies for controlling them. Policy prescriptions are unclear, though, since employers are loath to leave PBMs and nervous about pending changes to Medicare and Medicaid.