Mylan Labs announces final FDA approval for Albuterol Sulfate Extended-Release tablets

Tue Jan 30, 2007 3:51am EST

Co announces it has received final approval from the US F.D.A for its Abbreviated New Drug Application for Albuterol Sulfate Extended-release Tablets, 4mg and 8mg. Albuterol Sulfate E.R Tablets are the generic version of Dava Pharmaceutical's VoSpire ER, which had U.S. sales of approx $19 mln for the same strengths in the 12-month period ending Sept. 30, 2006, according to I.M.S Health. This product will be shipped immediately.

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