FDA approves first generic Ondansetron tablets.(Industry News)

Pharmaceutical Processing, February, 2007

The FDA has approved the first generic versions of Zofran (Ondansetron) 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-name drug in the United States in 2005, with sales totaling $839,256,543. "This approval will result in significant savings for the American public," said Gary J. 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."