Gary J. Buehler, Director, Office of Generic Drugs, says in a statement, "This approval is another example of our agency's efforts to increase access to safe and effective generic alternatives as soon as the law permits."
He adds, "Venlafaxine is a widely used antidepressant, and its generic version can bring significant savings to the millions of Americans diagnosed with MDD."
According to the FDA, the generic drug products are used to fill over 50 percent of all prescriptions and can cost a fraction of the price of the brand name drugs.
Venlafaxine Tablets 25 mg, 37.5 mg, 50 mg, 75 mg and 100 mg are manufactured by TEVA Pharmaceuticals USA in North Wales, PA.
This product will carry the same labeling and warnings as the originator drug. TEVA is eligible for 180 days of generic drug exclusivity. The FDA may approve other applications after the exclusivity period has expired.
