FDA Approves Nuvail; BioDelivery Plans To Submit NDA for Opioid Dependence Rx

Recent new drug activity at the Food and Drug Administration includes approval of a drug used to manage a nail condition, as well as a company’s plan to submit an application for an opioid dependence treatment.

Innocutis Sept. 18 announced that FDA has approved Nuvail (poly-ureaurethane, 16 percent) solution, a novel prescription product that helps manage fragile, damaged, or brittle nails with cracking or splitting, or “nail dystrophy.”

Innocutis, which is based in Charleston, S.C., said Nuvail is available at all major retail pharmacies and can be purchased by prescription in a 15-milliliter bottle.

NDA Submission Planned.

Also, BioDelivery Sciences ...