Sunday, October 17, 2010

A Fourth Generic Version Of Cozaar®/Hyzaar® (Losartan) Clears FDA

By my count, there are now at least four FDA-approved generic substitutes for Merck's Cozaar®/Hyzaar® -- this latest one (per Bloomberg), is produced by Mylan Labs:

. . . .Mylan Inc. said Friday it received approval to start selling generic versions of Merck and Co.'s blood pressure drugs Cozaar and Hyzaar.

The drugmaker from Canonsburg, Pa., has now received marketing approval for several doses of the drugs, but it was not able to sell them until this month. Its competitor Teva Pharmaceutical Industries Ltd. was the first company to file for approval of generic versions of the drug, so other versions were barred from the market for six months. Teva received FDA clearance in April.

The newly approved versions of the drug are ready for shipping immediately, Mylan said. . . .

As we mentioned about 12 days ago, Lupin is also FDA-cleared, and now selling, a generic form of Losartan. Prediction: the Q4 2010 Merck Cozaar/Hyzaar sales line will be off almost 75 percent, compared to Q4 2009. Ouch. So it goes.

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