The Food and Drug Administration (FDA) protects public health by guaranteeing the safety, effectiveness, and security of pharmaceuticals and medical devices. The Prescription Drug User Fee Act (PDUFA) date marks the deadline by which the FDA must complete its review of drug applications. Occasionally, an advisory committee (AdCom) meeting is convened to assess the drug or device under consideration. Presented below is a comprehensive list of drugs and devices, along with the anticipated decision date.
Upcoming FDA Decisions for September 2024
- AdCom Meeting Date: September 9, 2024
- Oral Sulopenem
- Iterum Therapeutics US Ltd.
- The Committee will discuss new drug application 213972, for oral sulopenem etzadroxil/probenecid tablets consisting of 500 milligrams (mg) sulopenem etzadroxil and 500 mg probenecid, for the proposed indication of treatment of uncomplicated urinary tract infections caused by designated susceptible bacteria in adult women 18 years of age and older.
- PDUFA Date: September 18, 2024
- Tradipitant
- Vanda Pharmaceuticals Inc.
- It is an NK-1R antagonist for the treatment of symptoms of gastroparesis.
- PDUFA Date: September 24, 2024
- IB1001
- IntraBio
- For the treatment of Niemann-Pick disease type C.
- PDUFA Date: September 25, 2024
- KEYTRUDA® (pembrolizumab) Plus Chemotherapy
- Merck
- An anti-PD-1 therapy, in combination with chemotherapy, for the first-line treatment of patients with unresectable advanced or metastatic malignant pleural mesothelioma.
- PDUFA Date: September 26, 2024
- KarXT
- Bristol Myers Squibb
- A first-in-class M1 / M4 muscarinic receptor agonist for the treatment of schizophrenia in adults.
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