Ibuprofen fails to make monograph threshold
This article was originally published in OTC Bulletin & The Rose Sheet
Executive Summary
The US Food and Drug Administration (FDA) has determined that ibuprofen does not meet the threshold for being permanently added to an OTC monograph and thus non-prescription products containing the analgesic ingredient must be approved through the agency’s new drug application (NDA) process.
You may also be interested in...
IGI Bets On Trispecific Antibody To Make Inroads Into Big Pharma Myeloma Turf
Ichnos Glenmark Innovation’s president and CEO talks to Scrip about the promising activity profile of the alliance’s early stage trispecific antibody versus Janssen’s teclistamab and also maintains that the setback for Gilead’s magrolimab hasn’t eclipsed prospects for its bispecific antibody.
UK Medtech Strategy Sets Out Schedule Of Milestones To FY 2026
Fourteen months on from the release of its inaugural medtech strategy, the UK MedTech Directorate has laid firm foundations and reports progress on initiatives aimed at improving technology adoption. A schedule of ambitious future timelines has also been published.
Chinese Firms Up Their Game In Novel Flu Antiviral Development
Joincare Pharmaceutical and partner TaiGen Biotechnology tout preliminary Phase III results in uncomplicated acute influenza for TG-1000, a homegrown follower of Shionogi/Roche’s oral antiviral Xofluza. Novel antivirals for flu were hotly pursued by Chinese developers throughout 2023.