Every month, Outbound Pharma compiles a list of the US FDA new drug approvals. The list includes New Drug Application (NDA) approvals, Biologics License Application (BLA) approvals and Abbreviated New Drug Application (ANDA) approvals.
FDA New Drug Approvals in February 2024
In the month of February 2024, the US FDA approved a total of 7 NDA/BLAs and 52 ANDAs. In addition, 5 BLAs were also approved by CBER.
Application type | Number of approvals | Approved by |
NDA/BLA | 7 | CDER |
ANDA | 52 | CDER |
BLA | 5 | CBER |
Compared to the same month last year, the FDA approved 7 more drugs:
NDA/BLA Drug (approved by CDER)
As part of the U.S. Food and Drug Administration (FDA), the Center for Drug Evaluation and Research (CDER) regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs.
In February 2024, the following drugs were approved for the first time by CDER:
1) LETYBO
Approval Date: 02/29/2024
Application number: BLA # 761225
Drug Name: LETYBO
Active Ingredients: LETIBOTULINUMTOXINA-WLBG
Company: HUGEL INC
Marketing Status: Prescription
Indication(s): Moderate-to-severe frown (glabellar) lines in adults
2) SIMLANDI
Approval Date: 02/23/2024
Application number: BLA # 761299
Drug Name: SIMLANDI
Active Ingredients: ADALIMUMAB-RYVK
Company: ALVOTECH USA INC
Marketing Status: Prescription
Indication(s): Adult rheumatoid arthritis, juvenile idiopathic arthritis, adult psoriatic arthritis, adult ankylosing spondylitis, Crohn’s disease, adult ulcerative colitis, adult plaque psoriasis, adult hidradenitis suppurativa and adult uveitis.
3) EXBLIFEP
Approval Date: 02/22/2024
Application number: NDA # 216165
Drug Name: EXBLIFEP
Active Ingredients: CEFEPIME HYDROCHLORIDE; ENMETAZOBACTAM
Company: ALLECRA THERAPEUTICS
Marketing Status: Prescription
Indication(s): Complicated urinary tract infections (cUTI) including pyelonephritis caused by designated susceptible microorganisms.
4) PANTOPRAZOLE SODIUM
Approval Date: 02/14/2024
Application number: NDA # 217512
Drug Name: PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE
Active Ingredients: PANTOPRAZOLE SODIUM
Company: BAXTER HELTHCARE CORP
Marketing Status: Prescription
Indication(s): Short-term treatment of gastroesophageal reflux disease (GERD) associated with a history of erosive esophagitis (EE), Pathological hypersecretion conditions including Zollinger-Ellison (ZE) Syndrome.
5) AURLUMYN
Approval Date: 02/13/2024
Application number: NDA # 217933
Drug Name: AURLUMYN
Active Ingredients: ILOPROST
Company: EICOS SCIENCES
Marketing Status: Prescription
Indication(s): Treatment of severe frostbite in adults to reduce the risk of digit amputations.
6) LEGUBETI
Approval Date: 02/13/2024
Application number: NDA # 215040
Drug Name: LEGUBETI
Active Ingredients: ACETYLCYSTEINE LYSINE
Company: GALEPHAR PHARMACEUTICAL
Marketing Status: Prescription
Indication(s): Antidote to prevent or lessen hepatic injury, which may occur following the ingestion of a potentially hepatotoxic quantity of acetaminophen, in adults and pediatric patients.
7) BUDESONIDE
Approval Date: 02/09/2024
Application number: NDA # 213976
Drug Name: EOHILIA
Active Ingredients: BUDESONIDE
Company: TAKEDA
Marketing Status: Prescription
Indication(s): Treatment in adult and pediatric patients 11 years of age and older with eosinophilic esophagitis (EoE)
Biological License Application Drug (approved by CBER)
The Center for Biologics Evaluation and Research (CBER) is one of the key centers within the Food and Drug Administration (FDA) that regulates Biological products.
In February 2024, the following BLAs were approved for the first time by CBER:
Approval Date: 02/28/2024
Drug Name: Elecsys Anti-HCV II
Company: Roche Diagnostics
Indication(s): An in vitro immunoassay for the qualitative detection of antibodies to hepatitis C virus (HCV) in human serum and plasma. It is intended to screen individual human donors, including volunteer donors of whole blood, blood components and source plasma. The assay is also intended to be used to screen organ, tissue and cell donors, when donor samples are obtained while the donor's heart is still beating. It is not intended for use on cord blood specimens
Approval Date: 02/27/2024
Drug Name: Elecsys Anti-HBc II
Company: Roche Diagnostics
Indication(s): An in vitro immunoassay for the qualitative detection of antibodies to hepatitis B core antigen (anti-HBc) in human serum and plasma. It is intended to screen individual human donors, including volunteer donors of whole blood and blood components. The assay is also intended to be used to screen organ, tissue and cell donors, when donor samples are obtained while the donor’s heart is still beating. It is not intended for use on cord blood specimens.
3) Elecsys HBsAg II and Elecsys HBsAg II Auto Confirm
Approval Date: 02/21/2024
Drug Name: Elecsys HBsAg II and Elecsys HBsAg II Auto Confirm
Company: Roche Diagnostics
Indication(s): An in vitro immunoassay intended for the qualitative detection of hepatitis B surface antigen (HBsAg) in human serum and plasma. It is intended to screen individual human donors, including volunteer donors of whole blood, blood components and source plasma. The assay is also intended to be used to screen organ, tissue and cell donors, when donor samples are obtained while the donor’s heart is still beating. It is not intended for use on cord blood specimens.
4) AMTAGVI (lifileucel)
Approval Date: 02/28/2024
Drug Name: AMTAGVI
Company: Iovance Biotherapeutics, Inc.
Indication(s): Treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor.
5) Elecsys Chagas
Approval Date: 02/05/2024
Drug Name: Roche Diagnostics
Company: Iovance Biotherapeutics, Inc.
Indication(s): An in vitro immunoassay for the qualitative detection of antibodies to Trypanosoma cruzi (T. cruzi, the causative agent of the Chagas disease) in human serum and plasma. It’s intended to screen individual human donors, including volunteer donors of whole blood and blood components. The assay is also intended to be used to screen organ, tissue and cell donors, when donor samples are obtained while the donor’s heart is still beating. It is not intended for use on cord blood specimens.
Sources: The information provided in this blog article is sourced from the official website of the United States Food and Drug Administration (FDA). https://www.fda.gov/.
What is included: This report includes all BLAs/NDAs/ANDAs approved by the Center for Drug Evaluation and Research (CDER), as well as Biological License Application approvals regulated by the Center for Biologics Evaluation and Research (CBER) (e.g. vaccines, in vivo diagnostic allergenic products, in vivo diagnostic tests for DTH, human blood and blood-derived products, immunoglobulin products, cellular and gene therapy products). What is not included: This report does not include Supplemental Approvals to NDAs and BLAs or ANDA supplement approvals or tentative ANDA approvals. It also does not include Biological Device Applications for devices involved in the collection, processing, testing, manufacture and administration of licensed blood, blood components and cellular products.
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