FDA OKs 15 Vyvanse Generics

FDA has approved 15 ANDAs representing the first generics of Vyvanse (lisdexamfetamine dimesylate) capsules and chewable tablets, Takeda’s attention-deficit/hyperactivity disorder drug. Vyvanse is also approved for treating moderate to severe binge-eating disorder in adults. Companies receiving approval were: Teva Pharmaceuticals, Sun Pharmaceutical, Ascent Pharmaceuticals, Specgx, Rhodes Pharmaceuticals, Prinston Pharmaceutical, Norwich Pharmaceuticals, Mylan Pharmaceuticals, Lannett, Hikma Pharmaceuticals, Ascent Pharmaceuticals, Apotex, Amneal Pharmaceuticals, Alkem Laboratories, and Actavis.

The approvals also included boxed warnings to inform healthcare providers and patients about the potential risk of abuse and dependence. “To address continuing concerns of misuse, addiction and overdose, FDA recently required updates to the labeling of prescription stimulants to standardize prescribing information and clearly inform patients, caregivers, and health care professionals of these risks,” an agency release notes.