U.S. Food and Drug Administration (FDA)
Is Pramlintide legal in United States?
Approved, restrictedApproved as Symlin in 2005 for mealtime insulin users with diabetes, but the maker has notified FDA it is discontinuing the product
Approved, but with limits on who can get it or how.
Pramlintide (Symlin, AstraZeneca) was FDA-approved on 16 March 2005 as an add-on for people with type 1 or type 2 diabetes who use mealtime insulin. Drugs@FDA now lists Symlin as discontinued, and FDA's shortage database has a notice dated 27 October 2025 that manufacture of the SymlinPen products is being discontinued. It has never been approved as a weight-loss drug. No generic pramlintide product was found in FDA data.
Last verified 2026-09-29 · how we verify
Pramlintide elsewhere
Sources (3)
- 01SYMLIN (pramlintide acetate) injection prescribing informationU.S. Food and Drug Administration · 2019-12 · accessed 2026-09-29
- 02Drugs@FDA data via openFDA: pramlintide application (Symlin, marketing status)U.S. Food and Drug Administration · 2026-09-24 · accessed 2026-09-29
- 03FDA Drug Shortages data via openFDA: pramlintide acetate injection (to be discontinued)U.S. Food and Drug Administration · 2025-10-27 · accessed 2026-09-29