FDA approves first generic ondansetron

The US Food and Drug Administration has approved the first generic versions of GlaxoSmithKline's 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, said the FDA, noting that, in 2005, ondansetron was the 20th highest-selling brand name drug in the USA, with sales totaling nearly $839.3 million, as reported in the on-line magazine Drug Topics.

The company receiving the clearance, and a 180-day exclusivity period, was Indian's Dr Reddy's Laboratories.

"This approval will result in significant savings for the American public," said Gary Buehler, director of the FDA's Office of Generic Drugs.