Quick answers
- What is Pramlintide acetate used for?
- The FDA-approved label (SymlinPen, AstraZeneca Pharmaceuticals LP, December 18, 2019) says: “SYMLIN is indicated as an adjunctive treatment in patients with type 1 or type 2 diabetes who use mealtime insulin therapy and who have failed to achieve desired glucose control despite optimal insulin therapy. SYMLIN is an amylin analog indicated for patients with type 1 or type 2 diabetes who use mealtime insulin and have failed to achieve desired glycemic control despite optimal insulin therapy.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Pramlintide acetate have a boxed warning?
- Yes. The FDA label for SymlinPen has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Pramlintide acetate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Pramlintide acetate been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Pramlintide acetate?
- 1 company lists prescription products of Pramlintide acetate in the FDA NDC Directory, including AstraZeneca Pharmaceuticals LP.
What Pramlintide acetate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
SYMLIN is indicated as an adjunctive treatment in patients with type 1 or type 2 diabetes who use mealtime insulin therapy and who have failed to achieve desired glucose control despite optimal insulin therapy. SYMLIN is an amylin analog indicated for patients with type 1 or type 2 diabetes who use mealtime insulin and have failed to achieve desired glycemic control despite optimal insulin therapy.
— FDA label: SymlinPen, AstraZeneca Pharmaceuticals LP, effective December 18, 2019. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
Forms and how it is given
| Dosage forms | Injection |
|---|---|
| Route | Subcutaneous |
| Prescription products | 2 in the FDA NDC Directory |
| Brand names | Symlinpen |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- AstraZeneca Pharmaceuticals LP2 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA021332 SYMLIN | Astrazeneca Ab | March 16, 2005 | 10, latest December 18, 2019 2019: Labeling · 2017: REMS · 2015: REMS |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 861042, 861043, 861044, 861045 |
|---|---|
| SPL set ID of the quoted label | 4aea30ff-eb0d-45c1-b114-3127966328ff |
| FDA labels (SPL) | 1 |
| FDA applications | NDA021332 |
| Active ingredients (FDA) | PRAMLINTIDE ACETATE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — SymlinPen, AstraZeneca Pharmaceuticals LP, effective December 18, 2019; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →