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COSENTYX

secukinumab · Injection

Prescription Biologic BLA TE TBD
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
COSENTYX
Generic name
secukinumab
Dosage form
Injection
Route
Subcutaneous
Marketing category
BLA · BLA
Labeler
Novartis Pharmaceuticals Corporation
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
3
NDC product codes
3
Packages
8
Data completeness
60% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Secukinumab 150 mg/mL 1599792 —
Secukinumab 300 mg/2mL 1599792 —
Secukinumab 75 mg/.5mL 1599792 —

Forms, strengths and routes

Source: NDC Directory
Dosage form
Injection
Route of administration
Subcutaneous
Presentations
11

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Interleukin-17A Antagonist [EPC] EPC 2 members — no class page
Interleukin-17A Antagonists [MoA] MoA 2 members — no class page

Regulatory status

Source: Drugs@FDANDC Directory
Application number
125504
Application type
BLA · Biologics License Application
Approval date
January 21, 2015
Sponsor
NOVARTIS PHARMS CORP
Products on application
1
Submissions recorded
25
Products approved under application 125504.
Product Trade name Form Strength Ingredient Status TE Flags
125504-001 COSENTYX INJECTABLE SECUKINUMAB Prescription TBD

Therapeutic equivalence

Source: Orange Book
TE code
TBD
Reference Listed Drug
No
Reference Standard
No

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA
Most recent submissions on application 125504.
Type No. Action Status Date Review
Supplement 98 Efficacy Approved April 17, 2026 Priority
Supplement 97 Efficacy Approved April 17, 2026 Priority
Supplement 91 Efficacy Approved March 12, 2026 Standard
Supplement 88 Labeling Approved August 6, 2025 Standard
Supplement 84 Labeling Approved March 12, 2025 Standard
Supplement 80 Labeling Approved October 4, 2024 Standard
Supplement 82 Labeling Approved August 16, 2024 Standard
Supplement 66 Labeling Approved November 21, 2023 Standard
Supplement 63 Efficacy Approved October 31, 2023 Standard
Supplement 73 Labeling Approved October 6, 2023 Standard
Supplement 67 Manufacturing (CMC) Approved July 24, 2023 N/A
Supplement 55 Labeling Approved July 24, 2023 Standard
Supplement 54 Labeling Approved July 24, 2023 Standard
Supplement 44 Efficacy Approved May 11, 2023 Standard
Supplement 51 Efficacy Approved December 22, 2021 Priority
Supplement 50 Efficacy Approved December 22, 2021 Priority
Supplement 43 Efficacy Approved May 28, 2021 Standard
Supplement 35 Efficacy Approved June 16, 2020 Priority
Supplement 31 Efficacy Approved January 29, 2020 Standard
Supplement 5 Efficacy Approved June 19, 2018 Standard
Supplement 13 Efficacy Approved January 23, 2018 Standard
Supplement 16 Labeling Approved September 15, 2017 Standard
Supplement 2 Efficacy Approved January 15, 2016 —
Supplement 1 Efficacy Approved January 15, 2016 Standard
Original application 1 Type 1 - New Molecular Entity Approved January 21, 2015 Standard

Review documents

  • 0 · Supplement · August 26, 2026
  • 0 · Supplement · April 21, 2026
  • 0 · Supplement · April 21, 2026
  • 0 · Supplement · April 21, 2026
  • 0 · Supplement · April 20, 2026
  • 0 · Supplement · April 20, 2026
  • 0 · Supplement · March 16, 2026
  • 0 · Supplement · August 21, 2025
  • 0 · Supplement · August 7, 2025
  • 0 · Supplement · March 24, 2025
  • 0 · Supplement · March 24, 2025
  • 0 · Supplement · March 14, 2025
  • 0 · Supplement · March 14, 2025
  • 0 · Supplement · October 9, 2024
  • 0 · Supplement · October 9, 2024
  • 0 · Supplement · August 20, 2024
  • 0 · Supplement · August 20, 2024
  • 0 · Supplement · August 19, 2024
  • 0 · Supplement · November 24, 2023
  • 0 · Supplement · November 22, 2023
  • 0 · Supplement · November 2, 2023
  • 0 · Supplement · November 2, 2023
  • 0 · Supplement · October 10, 2023
  • 0 · Supplement · October 10, 2023
  • 0 · Supplement · July 26, 2023
  • 0 · Supplement · July 26, 2023
  • 0 · Supplement · July 26, 2023
  • 0 · Supplement · July 25, 2023
  • 0 · Supplement · July 25, 2023
  • 0 · Supplement · July 25, 2023

Adverse event reports

Source: openFDA FAERS
160,421
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: SECUKINUMAB. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
0078-0639-41 0078-0639 Novartis Pharmaceuticals Corporation 2 mL in 1 CARTON (0078-0639-41) January 21, 2015
0078-0639-68 0078-0639 Novartis Pharmaceuticals Corporation 1 mL in 1 CARTON (0078-0639-68) January 21, 2015
0078-0639-97 0078-0639 Novartis Pharmaceuticals Corporation 1 mL in 1 CARTON (0078-0639-97) January 21, 2015
0078-0639-98 0078-0639 Novartis Pharmaceuticals Corporation 2 mL in 1 CARTON (0078-0639-98) January 21, 2015
0078-1056-97 0078-1056 Novartis Pharmaceuticals Corporation 1 SYRINGE, GLASS in 1 CARTON (0078-1056-97) / .5 mL in 1 SYRINGE, GLASS May 28, 2021
0078-1056-99 0078-1056 Novartis Pharmaceuticals Corporation 1 SYRINGE, GLASS in 1 CARTON (0078-1056-99) / .5 mL in 1 SYRINGE, GLASS May 28, 2021
0078-1070-68 0078-1070 Novartis Pharmaceuticals Corporation 1 SYRINGE, GLASS in 1 CARTON (0078-1070-68) / 2 mL in 1 SYRINGE, GLASS May 11, 2023
0078-1070-96 0078-1070 Novartis Pharmaceuticals Corporation 1 SYRINGE, GLASS in 1 CARTON (0078-1070-96) / 2 mL in 1 SYRINGE, GLASS May 11, 2023
0078-0639 0078-0639 Novartis Pharmaceuticals Corporation — January 21, 2015
0078-1056 0078-1056 Novartis Pharmaceuticals Corporation — January 21, 2015
0078-1070 0078-1070 Novartis Pharmaceuticals Corporation — January 21, 2015

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
FAERS FDA Adverse event report counts
Purple Book FDA Biologic licence classification

Generated September 25, 2026 · 10 sections on this page.