Adalvo advances in the development of Fidaxomicin Film Coated Tablets 200mg, expecting dossier completion within the next six months.
Following this, Adalvo intends to immediately file Fidaxomicin, having DCP slots already secured for Q4 this year.
This strategic move positions Adalvo among the first companies to file, maintaining our competitive edge in the market.
Fidaxomicin is based on the reference brand DIFICLIR and is indicated for treating Clostridioides Difficile Infections (CDI). In 2023, the brand recorded approximately $426 million with a 3Y CAGR of 22%, according to IQVIA.
Fidaxomicin has successfully passed rigorous pharmacokinetic trials, demonstrating its efficacy and reliability. This development highlights Adalvo's expertise in handling complex clinical programs and producing high-quality, difficult-to-make antibiotic products.
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