Zocor's Generic Versions Approved

The first generic versions of the anti-cholesterol drug Zocor have been approved by the U.S. Food and Drug Administration on friday.

Zocor has been prepared by Merck & Co. and is the 2nd-best selling statin drug in the United States after Pfizer's Lipitor. Statins which was designed to control high cholesterol and other fatty substances in the blood accounted for $ 16 billion in U.S. sales last year.

Although the generic versions of Zocor will be available, the drug will still require a prescription.

Generic simvastatin in 5 mg. 10 mg, 20 mg, and 40 mg doses will be produced by IVAX Pharmaceuticals Inc., of Northvale, N.J.
An 80 mg. dose of the drug will be made by Ranbaxy Pharmaceuticals Inc. of Princeton, N.J.

Teva Pharmaceuticals Industries Inc., an Israeli company, has already started shipping its versions of the four different dose strengths that have been approved to sell.

Indian drug maker, Ranbaxy Laboratories Ltd., has won approval to sell the highest dosage of the pill, which isn't commonly prescribed.

Judge Royce C. Lamberth of the U.S. District Court for the District of Columbia denied a motion for a temporary restraining order filed by another generic manufacturer, Sandoz Inc., to block the FDA from approving generic forms of Zocor made by Teva or Ranbaxy. The denial of the motion cannot be appealed.

However, Merck & Co.'s Zocor lost patent protection on Friday. It generated $ 4.4 billion last year and Merck has forecast sales of $ 2.3 billion to $ 2.6 billion in 2006.

Merck has also granted a license to Indian manufacturer Dr. Reddy's Laboratories Ltd. to sell a generic version of Zocor.
Novartis had filed another motion on Thursday that would block Teva and Ranbaxy from selling the drug. The companies have five days to file opposition to the motion. Lamberth is expected to make a ruling on this motion, which can be appealed, within 10 days.

Meanwhile, the FDA is appealing a federal judge's ruling that bestowed exclusivity on Teva and Ranbaxy. The appeal is being expected to be ruled out this summer and the outcome could affect how soon other companies are allowed to sell generic Zocor.

U.S.traded shares of Teva rose 94 cents, or 3 percent, to close at $ 32.19 Friday on the Nasdaq Stock Market at above average volume.

Dr. Reddy's shares added 60 cents, or more than 2 percent, to close at $ 27.53 on the New York Stock Exchange, while those of Novartis climbed 34 cents, or nearly 1 percent, to close at $ 52.63.