Every month, Outbound Pharma compiles a list of the US FDA new drug approvals. The list includes New Drug Applications (NDA), Biologics License Applications (BLA) and Abbreviated New Drug Application (ANDA) approvals.
FDA New Drug Approvals in March 2024
In March 2024, the US FDA approved a total of 15 NDA/BLAs and 43 ANDAs.
Application type | Number of approvals | Approved by |
NDA/BLA | 10/5 | CDER |
ANDA | 43 | CDER |
BLA | 0 | CBER |
Compared to the same month last year, the FDA approved more NDA/BLAs (+7), but fewer ANDAs (-52):
NDA/BLA Approvals
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 March 2024, the following drugs were approved for the first time:
1) VAFSEO
Approval Date: 03/27/2024
Application number: NDA # 215192
Drug Name: VAFSEO
Active Ingredients: VADADUSTAT
Company: AKEBIA THERAPEUTICS INC
Marketing Status: Prescription
Indication(s): treatment of anemia due to chronic kidney disease (CKD) in adults
2) WINREVAIR
Approval Date: 03/26/2024
Application number: BLA # 761363
Drug Name: WINREVAIR
Active Ingredients: SOTATERCEPT-CSRK
Company: MERCK SHARP DOHME
Marketing Status: Prescription
Indication(s): treatment of adults with pulmonary arterial hypertension
3) EFAVIRENZ, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE
Approval Date: 03/22/2024 (tentative approval)
Application number: NDA # 213509
Drug Name: EFAVIRENZ, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE
Active Ingredients: EFAVIRENZ, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE
Company: MYLAN
Marketing Status: Prescription
Indication(s): treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing at least 35 kg
4) OPSYNVI
Approval Date: 03/22/2024
Application number: NDA # 218490
Drug Name: OPSYNVI
Active Ingredients: MACITENTAN AND TADALAFIL
Company: ACTELION
Marketing Status: Prescription
Indication(s): chronic treatment of pulmonary arterial hypertension in adults
5) DUVYZAT
Approval Date: 03/21/2024
Application number: NDA # 217865
Drug Name: DUVYZAT
Active Ingredients: GIVINOSTAT
Company: ITALFARMACO
Marketing Status: Prescription
Indication(s): treatment of Duchenne muscular dystrophy (DMD) in patients 6 years of age and older.
6) TRYVIO
Approval Date: 03/19/2024
Application number: NDA # 217686
Active Ingredients: APROCITENTAN
Company: IDORSIA PHARMACEUTICALS
Marketing Status: Prescription
Indication(s): treatment of hypertension in combination with other antihypertensive drugs, to lower blood pressure in adult patients who are not adequately controlled on other drugs
7) EDURANT PED
Approval Date: 03/15/2024
Application number: NDA # 219016
Active Ingredients: RILPIVIRINE HYDROCHLORIDE
Company: JANSSEN
Marketing Status: Prescription
Indication(s): treatment of HIV-1 infection in treatment-naïve patients 2 years of age and older
8) CABAZITAXEL
Approval Date: 03/14/2024
Application number: NDA # 207970
Active Ingredients: CABAZITAXEL
Company: ACTAVIS (TEVA)
Marketing Status: Prescription
Indication(s): treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing treatment regimen
9) CABAZITAXEL INJECTION
Approval Date: 03/14/2024
Application number: NDA # 207970 (tentative approval)
Active Ingredients: CABAZITAXEL
Company: ACTAVIS (TEVA)
Marketing Status: Prescription
Indication(s): treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing treatment regimen
10) REZDIFFRA
Approval Date: 03/14/2024
Application number: NDA # 217785
Active Ingredients: RESMETIROM
Company: MADRIGAL
Marketing Status: Prescription
Indication(s): treatment of adults with noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis
11) TEVIMBRA
Approval Date: 03/13/2024
Application number: BLA #761232
Active Ingredients: TISLELIZUMAB
Company: BEIGENE
Marketing Status: Prescription
Indication(s): treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC)
12) TALZENNA
Approval Date: 03/07/2024
Application number: NDA # 217439
Active Ingredients: TALAZOPARIB TOSYLATE
Company: PFIZER
Marketing Status: Prescription
Indication(s): treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) HER2-negative locally advanced or metastatic breast cancer.
13) TYENNE
Approval Date: 03/05/2024
Application number: BLA # 761275
Active Ingredients: TOCILIZUMAB-AAZG
Company: FRESENIUS KABI USA
Marketing Status: Prescription
Indication(s): treatment of Rheumatoid Arthritis (RA), Giant Cell Arteritis (GCA), Polyarticular Juvenile Idiopathic Arthritis (PJIA) and Systemic Juvenile Idiopathic Arthritis (SJIA).
14) JUBBONTI
Approval Date: 03/05/2024
Application number: BLA # 761362
Active Ingredients: DENOSUMAB-BBDZ
Company: SANDOZ
Marketing Status: Prescription
Indication(s):
Treatment of postmenopausal women with osteoporosis at high risk for fracture. • Treatment to increase bone mass in men with osteoporosis at high risk for fracture. • Treatment of glucocorticoid-induced osteoporosis in men and women at high risk for fracture. • Treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer. • Treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.
15) WYOST
Approval Date: 03/05/2024
Application number: BLA # 761362
Active Ingredients: DENOSUMAB-BBDZ
Company: SANDOZ
Marketing Status: Prescription
Indication(s):
Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. • Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. • Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.
16) CLOBETASOL PROPIONATE
Approval Date: 03/04/2024
Application number: NDA # 218158
Active Ingredients: CLOBETASOL PROPIONATE
Company: FORMOSA
Marketing Status: Prescription
Indication(s): treatment of post-operative inflammation and pain following ocular surgery
BLA Approvals (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 March 2024, no new BLAs were approved.
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.
Disclaimer: While every effort has been made to ensure the accuracy and reliability of the information presented herein, it is important to acknowledge that errors or inaccuracies may inadvertently occur. Readers are advised to independently verify any information presented in this article and consult with qualified professionals or official sources for specific guidance or advice related to their individual circumstances. The author and publisher of this article disclaim any liability for any loss or damage resulting from reliance on the information provided herein. Furthermore, please be aware that the content of this article is intended for informational purposes only and should not be construed as medical, legal, or professional advice. Readers are encouraged to seek appropriate professional assistance or consultation as needed.
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