Mylan Inc. today announced that its subsidiary, Mylan Pharmaceuticals Inc., has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Venlafaxine Hydrochloride (HCl) Tablets 25 mg (base), 37.5 mg (base), 50 mg (base), 75 mg (base) and 100 mg (base).
Venlafaxine HCl Tablets, indicated for the treatment of major depressive disorder, are the generic version of Wyeth's Effexor(R) Tablets, which had annual U.S. sales of approximately $188 million for the 12 months ending March 31, 2008.
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