PHARMACY

Teva’s generic Aricept OKed by FDA

BY Alaric DeArment

JERUSALEM — The Food and Drug Administration has approved a generic drug for Alzheimer’s disease made by Teva Pharmaceutical Industries.

The FDA approved Teva’s donepezil hydrochloride tablets in the 5-mg and 10-mg strengths.

The drug is a generic version of Aricept, made by Pfizer and Eisai. Branded and generic versions of the drug had sales of about $2.3 billion during the 12-month period ended in March, according to IMS Health.

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PHARMACY

FDA: ARBs do not pose increased cancer risk

BY Alaric DeArment

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.

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Mylan gets go-ahead for generic Effexor XR

BY Alaric DeArment

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.

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