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Generic Betapace Receives Final Approval

PITTSBURGH, Feb. 8 /PRNewswire-FirstCall/ -- Mylan Laboratories Inc. (NYSE:MYL) today announced that Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Sotalol Hydrochloride Tablets USP (AF), 80mg, 120mg and 160mg.

Sotalol Hydrochloride Tablets USP (AF) are the generic version of Berlex Inc.'s Betapace AF(TM) Tablets, which had U.S. sales of approximately $10.5 million for the same strengths in the 12-month period ending Dec. 31, 2006, according to IMS Health.

This product will be shipped immediately.

Source: Mylan

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