PHARMACY

FDA approves Watson’s generic AccuNeb

BY Drew Buono

CORONA, Calif. The Food and Drug Administration has given final approval to Watson Pharmaceuticals for its application for the drug albuterol sulfate inhalation solution, the generic of AccuNeb, in the .021 and .042 percent strengths.

Watson has been awarded 180 days of market exclusivity for the .021 percent strength. Watson intends to launch its albuterol sulfate inhalation product immediately.

The drug is indicated for the relief of bronchospasm in patients 2 to 12 years of age with asthma. AccuNeb, for the 12 months ended June 2007 had sales of about $20 million in the U.S., according to IMS Health data.

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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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