PHARMACY

Sanofi-Aventis sues generic drug makers over Uroxatral

BY Drew Buono

WILMINGTON, Del. Sanofi-Aventis has sued a cluster of generic drug manufacturers including Teva, Actavis and Barr over its drug Uroxatral, indicated for treating prostate gland enlargement, according to Bloomberg.

The company states that the generic manufacturers are infringing on two U.S. patents, with their plans to market a generic version. Prostate enlargement usually occurs in men over 40, and about half of all men in their 60s have some related symptoms, according to Sanofi’s Web site.

Also sued were: Aurobindo Pharma, Mylan, Par, Ranbaxy, Sun, and Torrent.

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A new clinical data recently showed that patients with uncontrolled Type 2 diabetes treated with metformin were four times more likely to achieve recommended blood sugar control levels by adding Galvus to their treatment compared to those who took a place

BY Drew Buono

BASEL, Switzerland New clinical data recently showed that patients with uncontrolled Type 2 diabetes treated with metformin were four times more likely to achieve recommended blood sugar control levels by adding Galvus to their treatment compared to those who took a placebo, according to Novartis.

Galvus was approved last year by the Food and Drug Administration. The drug is a member of a new class of diabetes medicines called DPP-4 inhibitors, which also includes the drug Januvia, made by Merck.

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FDA bill currently in consideration to regulate prescription drug advertising

BY Drew Buono

WASHINGTON A new user fee program for Direct-To-Consumer broadcast ads will soon be put into law as part of a Food and Drug Administration bill working its way through Congress.

As a result, sponsors will soon have to tell the FDA how many of these ads it expects to submit for pre-view during the fiscal year 2008. Otherwise, you can be charged 50 percent for late penalty fees or lose your payment if you underestimate the number of ads you’ll run.

The FDA will be given power to determine what is acceptable and what is not, so it will be the job of the sponsors to conform to the FDA’s requirements to avoid those extra fees. The ads could be priced anywhere from $62,500 to $83,000, depending on how much money the FDA will need to keep the program going.

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