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Mylan's Venlafaxine hydrochloride tablets get FDA tentative approval
By Elaine Rigoli
Tampa, Fla., Aug. 14 - Mylan Laboratories, Inc. said the Food and Drug Administration has granted tentative approval for Mylan Pharmaceuticals, Inc.'s abbreviated New Drug Application for Venlafaxine hydrochloride tablets 25 mg (base), 37.5 mg (base), 50 mg (base), 75 mg (base) and 100 mg (base).
Venlafaxine is indicated for the treatment of major depressive disorder. They are the AB-rated generic version of Wyeth's Effexor tablets, which had annual U.S. sales of about $154 million for the 12 months ended June 30, according to a news release.
Mylan is a pharmaceutical company based in Canonsburg, Pa.
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