Fluocinolone acetonide 0.01%; otic drops; contains peanut oil. Discontinue if hypersensitivity reactions occur. Avoid eyes. Reevaluate if no improvement within 2 weeks. Pregnancy (Cat.C): not ...

The pharma major said that its New Jersey-based subsidiary Novel Laboratories has received approval from the US FDA for its abbreviated new drug application for fluocinolone acetonide oil.