FDA OKs REMS for Fentora, Actiq
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.
Under the REMS, healthcare professionals who prescribe the drugs and pharmacies that dispense them will enroll by completing an education module and knowledge assessment focused on safety information and appropriate patient selection, and prescribers will educate patients.
“The Fentora and Actiq REMS demonstrate Cephalon’s commitment to patient safety while maintaining access to these medicines for the often debilitating breakthrough pain experienced by many opioid-tolerant patients with cancer,” Cephalon chief medical officer Lesley Russell said. “The program provides education and systems to support safe use of Fentora and Actiq, preserving availability of the medicines to patients through retail pharmacies and using other systems already familiar to prescribers and pharmacists.”
Lannett receives regulatory approval for generic Adipex-P
PHILADELPHIA — The Food and Drug Administration has approved a drug for managing obesity made by Lannett.
Lannett announced the approval of phentermine hydrochloride capsules in the 37.5-mg strength, a generic version of Teva’s Adipex-P.
Phentermine hydrochloride capsules in the 37.5-mg strength had sales of about $8.8 million during the 12-month period ended in May, according to Wolters Kluwer.
Brilinta receives FDA approval
WILMINGTON, Del. — The Food and Drug Administration has approved a drug made by AstraZeneca to reduce the rate of heart attacks in patients with acute coronary syndrome, the Anglo-Swedish drug maker said.
AstraZeneca announced the approval of Brilinta (ticagrelor), a blood-thinning drug, on Wednesday. The drug maker is touting the drug as an alternative to Plavix (clopidogrel), made by Sanofi and Bristol-Myers Squibb.
“The FDA approval of Brilinta is good news for patients in the United States and represents a significant milestone as we seek to help ensure ACS patients around the world have access to this innovative medicine,” AstraZeneca CEO David Brennan said. “With [more than] 1 million people affected by ACS in the [United States] each year, the fact that physicians have a new and more effective treatment option than clopidogrel to help reduce the rate of heart attack and cardiovascular death in these patients is an important advance.”