Novolog® (insulin aspart recombinant)

BL 020986

Novolog® (insulin aspart recombinant)

BL 020986

U.S. License Holder:

Novo Nordisk Inc.

Date of License:

June-07-2000

Last Update:

Dec-15-2024

approved_indications FDA-Approved Indications

NOVOLOG (insulin aspart recombinant) is a rapid acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.

approved_indications aBLA / 505(b)(2) Activity

aBLA / 505(b)(2) Accepted by FDA

MYL-1601D: Viatris / Biocon (2021, Complete Response Letters January-2022, October-2023)

approved_indications Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In Canada

Kirsty (BGP Pharma (Viatris)) (October-2021)
Trurapi (Sanofi) (February-2021)

Biosimilars Approved In The E.U.

Insulin Aspart Sanofi (Sanofi) (July-2020)
Kirsty (previously Kixelle) (Viatris / Biocon) (February-2021)

Biosimilars Approved In Australia

Truvelog (Sanofi) (October-2020)

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Methodology

Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

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