FDA approves Impax’s generic Intuniv
HAYWARD Calif. — Impax Laboratories announced Thursday that the Food and Drug Administration had approved its generic version of Shire’s Intuniv (guanfacine) extended-release tablets.
The drug is indicated to treat attention deficit/hyperactivity disorder in children and adolescents ages 6 to 17. The drug will be available from Impax in 1-, 2-, 3- and 4-mg dosage strengths.
For the 12 months ended August 2015, brand and generic sales of guanfacine extended-release tablets were about $689 million.
FDA approves new hyperkalemia drug
SILVER SPRING, Md. — The Food and Drug Administration Thursday announced that it had approved Relypsa’s Veltassa (patiromer) for oral suspension. The drug is indicated to treat hyperkalemia, which is the presence of too much potassium in the blood and typically occurs among patients with kidney disease, or heart failure.
“We are very excited to bring people with hyperkalemia the first new medicine in more than 50 years,” Relypsa president and CEO John A. Orwin. “The FDA approval of Veltassa represents approximately a decade of research by dedicated scientists and doctors, and underscores Relypsa's commitment to developing polymer-based treatments for people with conditions that are often overlooked and undertreated.”
Veltassa, which is powdered, is mixed with water and taken by mouth. The drug works by binding potassium in the gastrointestinal tract, and the potassium is then excreted through the body through the normal excretion process. Veltassa was approved with a boxed warning, which recommends taking Veltassa and another oral medication six hours apart because it can bind to orally taken drugs and reduce their absorption, the FDA said.