FDA: ARBs do not pose increased cancer risk
SILVER SPRING, Md. — A class of drugs commonly used to control blood pressure does not increase patients’ risk of developing cancer, according to the Food and Drug Administration.
The FDA said Thursday that a review of 31 studies of angiotensin receptor blockers — a class that includes such drugs as Novartis’ Diovan (valsartan) and AstraZeneca’s Atacand (candesartan) — announced in July 2010 did not show an increased cancer risk associated with the drugs. The FDA began the review after the publication of a study that found a small, increased risk.
“The FDA has completed its review of controlled trial data on more than 155,000 patients randomized to ARBs or other treatments — the largest evaluation of such data to date — and finds no evidence of an increased risk of cancer in patients who take an ARB,” FDA Division of Cardiovascular and Renal Drugs deputy director Ross Southworth said.
Mylan gets go-ahead for generic Effexor XR
PITTSBURGH — The Food and Drug Administration has approved a generic drug for depression and anxiety made by Mylan, the drug maker said Thursday.
Mylan announced the approval of venlafaxine hydrochloride extended-release capsules in the 37.5-mg, 75-mg and 150-mg strengths.
The drug, used to treat major depressive disorder and social anxiety disorder, is a generic version of Effexor XR, made by Wyeth. Mylan is launching the drug under a licensing agreement it made with Wyeth before its purchase by Pfizer.
Velafaxine hydrochloride extended-release capsules had sales of $2.3 billion during the 12 months ended in March, according to IMS Health.
Drug shortage bill enters Senate
NEW YORK — Legislation recently introduced in the Senate aims to address the issue of drug shortages.
The Preserving Access to Life-Saving Medications Act, introduced in February by Sen. Amy Klobuchar, D-Minn., would require drug manufacturers to inform the Food and Drug Administration when supplies of a drug may be running low, allowing the agency to inform hospitals and attempt to address shortages.
The bill currently has nine cosponsors and is under review by the Senate Committee on Health, Education, Labor and Pensions, according to congressional records.