FDAnews
www.fdanews.com/articles/90386-fda-approves-first-generic-ondansetron-tablets-and-solution

FDA APPROVES FIRST GENERIC ONDANSETRON TABLETS AND SOLUTION

December 28, 2006

The FDA Dec. 27 approved the first generic versions of Zofran tablets, orally disintegrating tablets and oral solution, which are indicated to prevent nausea and vomiting associated with surgery, radiotherapy and cancer chemotherapy. The approval is an important step in the agency's effort to increase the availability of lower-cost generic medications. In 2005, Ondansetron was the 20th highest-selling brand drug in the U.S. in 2005, with sales totaling $839,256,543, as reported in the online magazine Drug Topics.

"This approval will result in significant savings for the American public," said Gary Buehler, director, Office of Generic Drugs. "Generic drugs are safe and effective alternatives to brand name drugs and undergo a thorough scientific and regulatory review."

The economic benefits of the FDA's generic drug approval program are significant because generic drug products, which are used to fill over 50 percent of all prescriptions, frequently cost a fraction of the price of the brand drugs. Such savings are likely to increase as more competitors enter the market.