The October approvals include treatments for acute pain, opioid overdose, dry eye disease, and COVID-19 vaccine for children 5 to 11 years of age.
Drug previously approved for treatment of complicated intra-abdominal infections, UTIs.
In randomized trial, drug demonstrated statistically significant improvement in progression-free survival.
Ruzurgi previously approved for treatment in adults with Lambert-Eaton myasthenic syndrome.
The expanded approval was based on safety and efficacy data from a confirmatory Phase 3 randomized, double-blind, placebo-controlled multicenter study evaluating Osphena in patients with moderate to severe vaginal dryness.