Fiasp, Fiasp Flextouch, Fiasp Penfill

For diabetes mellitus. BLA 208751, held by Novo. Insulin Aspart.

As of Nov 13, 2026, BLA 208751 (Fiasp, Fiasp Flextouch, Fiasp Penfill), held by Novo, was first approved by FDA on Sep 29, 2017, with 10 approved supplements and 0 published complete response letters.

First approved: Sep 29, 2017
Review: Standard
Supplements approved: 10
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

FIASP is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.

Full prescribing information on DailyMed ↗

Approvals and New Uses

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

Date	Submission	Status	Documents
Dec 19, 2019	Supplement 10Efficacy (new indication or use) · Standard review	Approved	Letter Label Pediatric CDTL Review Pediatric Medical Review
Dec 19, 2019	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Oct 21, 2019	Supplement 8Efficacy (new indication or use) · Standard review	Approved	Label Letter
Sep 29, 2017	Original applicationNew formulation or manufacturer · Standard review	Approved	Label Letter Review

Products

3 strengths and forms

Product	Active ingredient	Marketing
Fiasp1000 UNITS/10ML (100 UNITS/ML) · solution;intravenous, subcutaneous	Insulin Aspart	Rx
Fiasp Flextouch300 UNITS/3ML (100 UNITS/ML) · solution;subcutaneous	Insulin Aspart	Rx
Fiasp Penfill300 UNITS/3ML (100 UNITS/ML) · solution;subcutaneous	Insulin Aspart	Rx

All 11 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jun 21, 2023	Supplement 20Labeling · Standard review	Approved	Letter Label
Dec 19, 2019	Supplement 10Efficacy (new indication or use) · Standard review	Approved	Letter Label Pediatric CDTL Review Pediatric Medical Review
Dec 19, 2019	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Nov 15, 2019	Supplement 12Labeling · Standard review	Approved	Letter Label
Oct 21, 2019	Supplement 8Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 21, 2019	Supplement 13Labeling	Approved	Label Letter
Sep 24, 2018	Supplement 3Manufacturing	Approved	Other
Sep 4, 2018	Supplement 5Labeling · Standard review	Approved	Other Other
Jul 22, 2018	Supplement 2Manufacturing	Approved	None posted
Mar 6, 2018	Supplement 1Labeling · Standard review	Approved	Other Other
Sep 29, 2017	Original applicationNew formulation or manufacturer · Standard review	Approved	Label Letter Review

Identifiers

Application: BLA 208751
Drugs@FDA: Overview at FDA
Company: Novo

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