The announcement last week that the Food and Drug Administration has approved a generic version of Effexor (venlafaxine), is good news for individuals prescribed the depression medication. Despite the cost difference between brand names and generics, the quality standards are the same.
Consumers often do not realize that drug products sold in the United States are approved by the FDA whether they are brand name or generic. And, in fact, availability of lower cost generic drugs has been high priority for the FDA.
“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,” said Gary J. Buehler, Director, Office of Generic Drugs. “Venlafaxine is a widely used antidepressant, and its generic version can bring significant savings to the millions of Americans diagnosed with MDD.”
New drugs, like other new products, are developed under patent protection. The patent protects the investment in the drug’s development by giving the company the sole right to sell the drug while the patent is in effect. When patents or other periods of exclusivity on brand-name drugs are near expiration, manufacturers can apply to the FDA to sell generic versions.
The economic benefits of FDA’s generic drug approval program are significant because 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. Competition from generic drugs that are safe and effective alternatives may quickly lead to reductions in spending. The savings would likely increase as more competitors enter the market.
Venlafaxine Tablets 25 mg, 37.5 mg, 50 mg, 75 mg and 100 mg are manufactured by TEVA Pharmaceuticals USA (TEVA) in North Wales, PA. This product will carry the same labeling including the black box warning 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.
The Office of Generic Drugs continues working expeditiously to review and take action on generic drug applications as quickly as possible. For more information on other first generic versions, please see http://www.fda.gov/cder/ogd/approvals/1stgen0506.htm
For additional information related to FDA’s Office of Generic Drugs, please go to: http://www.fda.gov/cder/consumerinfo/generic_equivalence.htm