Adalvo announces the successful ANDA submission to the U.S. FDA for Fidaxomicin 200mg tablets. This marks a key milestone in bringing a high-quality, difficult-to-make anti-infective treatment to the U.S. market.
The submission is backed by positive pivotal bioequivalence (BE) studies, underscoring the strength of Adalvo’s global development programs and technical expertise in navigating complex pharmacokinetic requirements.
Fidaxomicin, a complex macrocyclic antibiotic, is indicated for the treatment of Clostridioides difficile infections (CDI), a serious and potentially life-threatening gastrointestinal condition requiring targeted antibiotic therapy. According to IQVIA, global sales for Fidaxomicin reached approximately $512 million in 2024, with a 3-year CAGR of 21%, reflecting strong clinical relevance and sustained commercial performance.
This ANDA filing aligns with Adalvo’s strategic focus on early market access and regulatory precision. The product is part of Adalvo’s broader anti-infectives portfolio, which is built around technically challenging, high-value opportunities for partners in regulated markets.
To explore licensing or commercial partnership opportunities within Adalvo’s anti-infectives portfolio for US and global markets, contact the team today.