FDA Approves First Generic Ondansetron Injection

The U. S. Food and Drug Administration (FDA) today approved first generic versions of Zofran (Ondansetron) Injection and Zofran (Ondansetron) Injection Premixed.

Ondansetron is indicated for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy (cancer therapy that causes vomiting) and prevention of postoperative nausea and vomiting. According to the online magazine Drug Topics, Zofran was the 20th most expensive brand-name drug used in hospitals in the United States, in 2005, with total costs of $839.26 million.

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

Ondansetron Injection packaged in single (4 mg/2 mL) and multi-dose (40 mg/20 mL) vials are manufactured by Teva Pharmaceuticals USA in North Wales, PA. Ondansetron Injection Premixed, 32 mg/50 mL in 5 percent dextrose is manufactured by SICOR Pharmaceuticals, Inc. in Irvine, CA. GlaxoSmithKline, the manufacturer of the innovator drug, has agreed to waive the remainder of a six-month exclusivity period to permit approval of the applications submitted by Teva and SICOR Pharmaceuticals.

The economic benefits of FDA's generic drug approval program are significant because generic drug products are used to fill more than 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 to brand name drugs may quickly lead to reductions in costs.  The savings would likely increase as more competitors enter the market. (See www.fda.gov/cder/ogd/generic_competition.htm).

The Office of Generic Drugs (OGD) continues to review and take action on generic drug applications as quickly as possible.  For more information on other first generic versions of innovator products, see www.fda.gov/cder/ogd/approvals/1stgen0506.htm.

For additional information related to FDA's Office of Generic Drugs, go to: www.fda.gov/cder/consumerinfo/generic_equivalence.htm.

####