Today's sweep found genuine regulatory activity rather than a quiet day. A generic dapagliflozin application from Ajanta Pharma was approved on 2 September, adding another manufacturer to a molecule whose price has been the main obstacle to prescribing it at scale. Where an SGLT2 inhibitor was rationed by cost, that arithmetic changes as generics arrive, and it is worth revisiting patients with heart failure or chronic kidney disease who were assessed as eligible but priced out.
Separately, and more urgently, the FDA has an ongoing Class II recall of compounded semaglutide multi-dose vials from Apollo Care for particulate matter identified as nylon or polyamide and silk or proteinaceous material. Class II means temporary or medically reversible harm is possible. This concerns compounded vials rather than the manufacturer's pens, which matters because compounded semaglutide reaches patients through channels that do not always tell them what they have received.
Ask any patient on semaglutide where it came from and what it looked like. A patient using a multi-dose vial rather than a branded pen is on a compounded product, and should be told to inspect it and stop if anything is visible in the solution.
- Generic dapagliflozin approved 2 September, a further step down in cost
- Revisit patients with heart failure or CKD who were eligible but could not afford it
- Class II recall of compounded semaglutide multi-dose vials for particulate matter
- Ask patients whether they use a vial or a pen; a vial means a compounded product
Read the rest in the app
You have read your two free briefings this month. The app carries all 27 specialties, every morning, free — and this finding is waiting in it.
Scan to keep reading on your phone. No account needed to start.
Tomorrow morning, before your first patient
One edition a day for diabetes & endocrinology, written by the desk, every claim tied to its paper. Six minutes.
Get the app — free