Content about Actiq

January 23, 2012

The Food and Drug Administration is streamlining the enrollment process for risk evaluation and mitigation strategies for a class of painkillers, the agency said.

SUPPLIER NEWS — The Food and Drug Administration is streamlining the enrollment process for risk evaluation and mitigation strategies for a class of painkillers, the agency said. The FDA announced the approval of a single REMS for transmucosal immediate-release fentanyl 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.

January 3, 2012

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.

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.

October 10, 2011

The Federal Trade Commission has given Teva Pharmaceutical Industries the green light to acquire Frazer, Pa.-based drug maker Cephalon, but with some restrictions, Teva said.

JERUSALEM — The Federal Trade Commission has given Teva Pharmaceutical Industries the green light to acquire Frazer, Pa.-based drug maker Cephalon, but with some restrictions, Teva said.

Before it can complete the $6.8 billion deal, Teva must sell to Par Pharmaceutical Cos. its generic versions of two Cephalon drugs, namely generic versions of the cancer pain drug Actiq (fentanyl citrate) and the muscle relaxant drug Amrix (cyclobenzaprine), which have combined sales of $298 million per year, according to IMS Health.

July 21, 2011

The Food and Drug Administration has approved a risk evaluation and mitigation strategy for two painkillers made by Cephalon, the drug maker said Thursday.

FRAZER, Pa. — The Food and Drug Administration has approved a risk evaluation and mitigation strategy for two painkillers made by Cephalon, the drug maker said Thursday.

The FDA approved a REMS for Fentora (fentanyl) buccal tablets and Actiq (oral transmucosal fentanyl citrate). Both drugs are used for managing breakthrough pain in cancer patients who have become tolerant of opioid drugs.

June 23, 2010

The Food and Drug Administration has given tentative approval to Watson Pharmaceuticals for a generic...