NDAORALFOR SUSPENSION, DELAYED RELEASE
Approved
May 2021
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
NOXAFIL POWDERMIX KIT (posaconazole) by Merck & Co. is 12. First approved in 2021.
Drug data last refreshed 18h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NOXAFIL POWDERMIX KIT is a delayed-release oral suspension formulation of posaconazole, an azole antifungal agent that inhibits fungal ergosterol synthesis. It is indicated for prophylaxis of invasive Aspergillus and Candida infections in severely immunocompromised patients, including those undergoing chemotherapy for AML/MDS or hematopoietic stem cell transplant recipients with GVHD. The powder formulation offers improved bioavailability and patient convenience compared to earlier suspension formulations.
Peak2.4 years to LOE
Product is in peak commercial phase with moderate competitive pressure (30); brand team likely stable-to-growing as formulation expansion continues post-launch.
Mechanism of Action
12.1 Mechanism of Action Posaconazole is an azole antifungal agent [see ] . 12.2 Pharmacodynamics Exposure Response Relationship: Prophylaxis of invasive Aspergillus and Candida Infections in Adults Who Are at High Risk of Developing These Infections Due to Being Severely Immunocompromised In…
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.