FDA approves new REMS for fentanyl-based painkillers
SILVER SPRING, Md. — The Food and Drug Administration is streamlining the enrollment process for risk evaluation and mitigation strategies for a class of painkillers, the agency said Tuesday.
The FDA announced the approval of a single REMS for transmucosal immediate-release fentanyl, or TIRF, drugs. The new system, which takes effect in March, will allow prescribers and pharmacies to enroll into one system instead of individual systems for each product. TIRF drugs include ProStrakan’s Abstral, Cephalon’s Fentora and Actiq, Archimedes Pharma’s Lazanda and Meda Pharmaceuticals’ Onsolis.
"This TIRF REMS will ensure safe use and access to these drugs for patients who need them," FDA Center for Drug Evaluation and Research director Janet Woodcock said. "We have worked with the sponsors of both the innovator and generic drugs to develop this single, shared system that will streamline the process and decrease the burden of the REMS on the healthcare system."
FDA panel to review potential new use for Xgeva
THOUSAND OAKS, Calif. — Drug maker Amgen will discuss the supplemental biologics license application of Xgeva before a Food and Drug Administration review panel next month.
Amgen will participate in a meeting of the Oncologic Drugs Advisory Committee on Feb. 8, where the panel will review results from clinical studies in support of Xgeva as a treatment of castration-resistant prostate cancer in men that are at high risk of developing bone metastases, a new indication for the drug. The company said there currently is no approved treatments to delay or prevent the spread of cancer to bone among this specific patient population.
The sBLA was submitted this past June, and a Prescription Drug User Fee Act action date has been scheduled for April 26 of this year. If approved, this will be the second indication of Xgeva in the United States.
Teva leader to exit company in May, former Bristol executive to step in
JERUSALEM — Teva Pharmaceutical Industries announced that Shlomo Yanai, president and CEO, will retire from his post in May.
Yanai, who has served in this capacity for five years, has helped Teva expand from a mainly generics business to a more diversified pharmaceutical company, with expected 2012 revenue of approximately $22 billion, and an expanded footprint in the European, Asian and Latin America markets.
Yanai will be succeeded by former Bristol-Myers Squibb executive Jeremy Levin. At Bristol, Levin direct responsibility for strategy, alliances and transactions, and managed its portfolio of alliances.