FDA — authorised 25 September 2007
- Application: NDA021332
- Marketing authorisation holder: ASTRAZENECA AB
- Indication: Manufacturing (CMC)
- Status: approved
FDA authorised Symlin on 25 September 2007 · 98 US adverse-event reports
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 25 September 2007.
ASTRAZENECA AB holds the US marketing authorisation.