Symproic or naldemedine fda approval date nda 208854?

Which drug was FDA-approved under NDA 208854?

NDA 208854 corresponds to Symproic (naldemedine). The FDA approval date for Symproic under NDA 208854 is June 16, 2017.

If you meant to verify a different NDA number, share the NDA you’re checking and I can match it to the correct product and approval date.

What does Symproic’s approval relate to (quick context)?

Symproic (naldemedine) is approved for opioid-induced constipation (OIC) in patients with chronic non-cancer pain, as well as certain adult patients with OIC in the setting of cancer when taking opioids for pain.

Want the exact FDA approval entry?

If you want, tell me whether you’re looking for the original approval date or a supplement approval date (sometimes a later label update can be tied to the same NDA record).