The Prescription Drug User Fees Act (PDUFA) date refers to the deadline set by the U.S. Food and Drug Administration (FDA) to review a New Drug Application (NDA) or Biologics License Application (BLA) and make a final decision on marketing approval. The typical review period is 10 months after the FDA accepts the drug application. For priority review drugs, the review period is shortened to 6 months from the date of acceptance. Here is a list of five drugs that will make an FDA drug approval decision in April:
This is a broad-spectrum cephalosporin antibiotic that has been shown to have rapid bactericidal activity against Gram-positive bacteria such as Staphylococcus aureus, including methicillin-resistant strains (MRSA)) and Gram-negative bacteria.
PDUFA Date: April 3, 2024.
This is a combination of apomorphine infusion devices that provide a sustained burst of motor fluctuations (intermittent episodes) for people with Parkinson's disease.
PDUFA Date: April 5, 2024.
N-803 (Anktiva) is an interleukin-15 (IL-15) super-agonist complex consisting of an IL-15 mutant (IL-15N72D) that binds to the IL-15 receptor IgG1FC fusion protein. The investigational drug is being reviewed in combination with BCG for non-muscle-invasive bladder carcinoma in situ with or without TA or T1 lesions.
PDUFA Date: April 23, 2024.
This is an oral, brain-permeable, highly selective type II RAF kinase inhibitor designed to target key enzymes in the MAPK signaling pathway. It is currently being reviewed for use in *** or progressive pediatric low-grade glioma.
PDUFA Date: April 30, 2024.
This is an investigational oral CXCR4 receptor small molecule antagonist. The drug is currently being reviewed for use in patients with Whim syndrome aged 12 years and older. This is a rare primary immunodeficiency in which WHIM is an acronym for warts, hypogammaglobulinemia, infection, and ineffective generative chronic agranulocytosis.
PDUFA Date: April 30, 2024.
Note: The purpose of this article is to introduce medical and health research, and does not make any basis for medication.