Regulatory and Washington

SILVER SPRING, Md. — The Food and Drug Administration has approved a new antiretroviral treatment for HIV made by Johnson & Johnson, the agency said Friday.

The FDA approved J&J subsidiary Tibotec Therapeutics’ Edurant (rilpivirine) as a treatment for use in combination with other HIV drugs in adults who have not been treated before.

DUBLIN — Sandoz is looking to market a generic version of a Shire drug for treating attention deficit hyperactivity disorder.

ABBOTT PARK, Ill. — A Food and Drug Administration advisory committee has voted to recommend that the FDA retain approval of an Abbott drug for high cholesterol in combination with a statin.

The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee met Thursday to discuss whether to recommend continued FDA approval of Trilipix (fenofibric acid) in combination with simvastatin in patients with mixed dyslipidemia and a high risk of heart disease. The FDA is not bound by advisory committee votes, but usually follows them.

WASHINGTON — The Council for Responsible Nutrition on Thursday issued a statement regarding the growing controversy surrounding Lazy Cakes — a brownie containing melatonin, an ingredient that helps establish more normal sleeping patterns — that has been cited in a New York Times article as having “flagrantly mimic[ked] the soothing effects of hash brownies.”

Other published reports suggested the Arizona Department of Health issued a mandatory recall of Lazy Cakes following the report of an adverse event.

WASHINGTON — The National Retail Federation on Wednesday launched a 60-day lobbying, grassroots and media campaign aimed at ensuring that a new federal law — which is designed to save retailers and their customers more than $1 billion a month by lowering the “swipe fees" banks charge to process debit card transactions — takes effect in late July as scheduled.

CHICAGO — Theodore Kaczynski, also known as the Unabomber, allegedly is a suspect in the 1982 Tylenol poisonings in the Chicago area that killed seven people, according to published reports.

The Tylenol poisonings, in which someone placed potassium cyanide in with the pain relievers on store shelves, prompted the introduction of tamper-proof packaging for many over-the-counter medicines.

SILVER SPRING, Md. — Two Food and Drug Administration advisory committees on Wednesday unanimously voted in favor of mandating weight-based dosing for children between the ages of 2 and 12 years who are being administered acetaminophen.

ATLANTA — The Centers for Disease Control and Prevention posted an attention-grabbing page Wednesday titled: “Preparedness 101: Zombie Apocalypse.”

“There are all kinds of emergencies out there that we can prepare for,” the CDC stated on the Web page. “Take a zombie apocalypse for example. … You may laugh now, but when it happens you’ll be happy you read this, and hey, maybe you’ll even learn a thing or two about how to prepare for a real emergency.”