Adalvo reports significant progress in the development of Fidaxomicin Film Coated Tablets, with the dossier on track for global submission by the end of 2024.
As we gear up for the imminent filing process, this advancement reflects Adalvo’s commitment to maintaining its competitive position. With DCP slots planned for the end of Q4 2024, Adalvo's global-first strategy ensures we remain among the initial filers, securing a strong market presence across multiple regions.
Fidaxomicin, based on the reference brand Dificlir, is indicated for treating Clostridioides Difficile Infections (CDI). The brand achieved approximately $426 million in sales in 2023, with a robust 3Y CAGR of 22%, according to IQVIA.
The project’s success so far, including its challenging pharmacokinetic trials, reflects Adalvo’s expertise in navigating complex clinical programs and delivering difficult to make and high-quality antibiotic products to the global market.
At Adalvo, there are no half-measures – we are always on target. When your mission is to be faster and stronger than your competitors, you need a winning team driving your vision forward.
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