FDA approves a Novo Nordisk Type 1 diabetes treatment
WASHINGTON The Food and Drug Administration announced Thursday that it had approved Novo Nordisk’s NovoLog Mix 50/50, a treatment for Type 1 diabetes.
The drug, approved Aug. 26, is related to, but distinct from, NovoLog and NovoLog Mix 70/30. It comprises 50 percent insulin aspart protamine and 50 percent insulin aspart.
NACDS applauds Senate bill to curb illegal meth production
ALEXANDRIA, Va. Acting to halt the illegal production and abuse of methamphetamines, the Senate has passed new legislation to strengthen the ability of law enforcement and pharmacy operators to combat the problem.
The National Association of Chain Drug Stores today praised passage of the bill, known as the Methamphetamine Production Prevention Act. If signed into law, the proposal would spur the adoption of methamphetamine precursor electronic logbook systems, thus providing law enforcement with easier access to information and streamlining recordkeeping requirements for pharmacies.
“The chain pharmacy industry recognizes the importance of addressing the serious methamphetamine problem,” noted NACDS Thursday. “In fact, prior to the introduction of state and federal legislation, the majority of chain pharmacies took voluntary, proactive steps to reduce the theft and illegitimate use of legitimate products that contain methamphetamine precursors, that is, products containing pseudoephedrine and ephedrine. Pharmacies took these steps despite the possibility that instituting barriers could lead to consumer complaints and reduced sales.”
“We greatly appreciate your willingness to engage us throughout the drafting process,” NACDS president and CEO Steven Anderson told the lawmakers. “We commend you for developing strong legislation that will assist retailers and law enforcement to combat the serious problem of illicit methamphetamine production and abuse.”
NACDS also applauded original cosponsors Senators Diane Feinstein (D-CA) and Joe Biden (D-DE) for their support of S. 1276.
“Senate passage of this legislation sends an important message that preventing the illegal production and abuse of methamphetamine is imperative to our nation’s well being,” said Anderson. “S. 1276 will help law enforcement efforts, while also allowing increased efficiency in logging meth precursor sales. We encourage the House to join the Senate in passing this legislation so that it can be enacted into law.”
Cephalon fights allegations of falsely promoting drugs for the wrong use
FRAZER, Pa. Cephalon has finalized an agreement with the United States Attorney’s Office for the Eastern District of Pennsylvania, the Department of Justice and other federal agencies concerning allegations that it promoted three drugs for uses that the Food and Drug Administration had not approved, the company announced Monday.
The allegations concerned the cancer-related pain drug Actiq (oral transmucosal fentanyl citrate), the sleep-disorder drug Provigil (modafinil) and the seizure drug GabitRil (tiagabine hydrochloride). Under the terms of the agreement, Cephalon will pay $425 million reserved last year plus $12 million interest and plead guilty to a single misdemeanor violation of the Food, Drug and Cosmetic Act. It will also enter into a five-year Corporate Integrity Agreement with the Office of the Inspector General of the Department of Health and Human Services.