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Generic Lopressor Approved by FDA

PITTSBURGH, Aug. 23 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc. (NYSE:MYL) today announced that the U.S. Food and Drug Administration (FDA) has granted final approval for Mylan Pharmaceuticals' Abbreviated New Drug Application (ANDA) for Metoprolol Tartrate and Hydrochlorothiazide Tablets, 50/25 mg, 100/25 mg, and 100/50 mg strengths. Metoprolol Tartrate and Hydrochlorothiazide Tablets are the generic version of Novartis' Lopressor HCT(R) Tablets.

Mylan also announced that the FDA has granted tentative ANDA approval for Mylan Pharmaceuticals' Cetirizine Hydrochloride Tablets, 5 mg and 10 mg, and Sertraline Hydrochloride Tablets, 25 mg (base), 50 mg (base) and 100 mg (base). Cetirizine Hydrochloride and Sertraline Hydrochloride are the generic versions of Pfizer's Zyrtec(R) and Zoloft(R), respectively.

Source: Mylan Laboratories Inc.

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