Vivjoa Approved for Recurrent Vulvovaginal Candidiasis
The approval was based on data from three phase 3 trials, which included female patients aged 12 years and older with at least 3 episodes of acute VVC in the past 12 months.
The approval was based on data from three phase 3 trials, which included female patients aged 12 years and older with at least 3 episodes of acute VVC in the past 12 months.
The phase 3 CANDLE study compared the efficacy and safety of ibrexafungerp to placebo in 260 female patients 12 years of age and older with rVVC.
The pivotal phase 3 ReSTORE study included 187 adults diagnosed with candidemia and/or invasive candidiasis.
Lotrimin and Tinactin spray products are over the counter topical antifungals.
The recall was initiated because the product had prolonged exposure to extremely cold weather during shipment.
The NDA submission is supported by data from three phase 3 trials, which included 2 global studies and one US-focused study.
There were 101 Candida auris cases at a nursing home and 22 cases at hospitals from January to April
The approval was based on data from two phase 3 trials that compared Brexafemme to placebo in female patients aged 12 years and older with acute VVC.
Oteseconazole is a novel oral inhibitor of fungal CYP51.