Symlin

For type 1 or type 2 diabetes. NDA 21332, held by Astrazeneca AB. Pramlintide Acetate.

As of Nov 14, 2026, NDA 21332 (Symlin), held by Astrazeneca AB, was first approved by FDA on Mar 16, 2005, with 10 approved supplements and 0 published complete response letters.

First approved: Mar 16, 2005
Review: Standard
Supplements approved: 10
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below


Jun 27, 2014	Supplement 7Efficacy (new indication or use)	Approved	Label Letter
Mar 16, 2005	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Products

3 strengths and forms


SymlinEQ 3MG BASE/5ML (EQ 600MCG BASE/ML) · injectable;subcutaneous	Pramlintide Acetate	Discontinued
SymlinEQ 1.5MG BASE/1.5ML (EQ 1MG BASE/ML) · injectable;subcutaneous	Pramlintide Acetate	DiscontinuedReference drug
SymlinEQ 2.7MG BASE/2.7ML (EQ 1MG BASE/ML) · injectable;subcutaneous	Pramlintide Acetate	DiscontinuedReference drug

All 11 submissions, including labeling and manufacturing supplements


Dec 18, 2019	Supplement 28Labeling · Standard review	Approved	Letter Label
Mar 8, 2017	Supplement 26REMS	Approved	Letter
Aug 7, 2015	Supplement 24REMS	Approved	Letter
Mar 20, 2015	Supplement 25Labeling · Standard review	Approved	Letter Label
Feb 25, 2015	Supplement 23Labeling	Approved	Label Letter
Jun 27, 2014	Supplement 7Efficacy (new indication or use)	Approved	Label Letter
Jun 27, 2014	Supplement 16Labeling · Standard review	Approved	Label Letter
Jan 3, 2012	Supplement 20Labeling · Standard review	Approved	Letter
Aug 4, 2008	Supplement 10Labeling · Standard review	Approved	Letter
Sep 25, 2007	Supplement 6Manufacturing	Approved	Letter Label
Mar 16, 2005	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21332
Drugs@FDA: Overview at FDA
Company: AstraZeneca Pharmaceuticals LP

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters