FDA Yanks Ondansetron NDA, ANDAs for Safety Reasons

June 15, 2015

The FDA is withdrawing approval of one NDA and four ANDAs for ondansetron, effective immediately, due to a potentially life-threatening complication with the drug.

The drugs were removed from the U.S. market late 2012, following a September 2011 drug safety communication warning of an increased risk of irregular heart rhythm.

The announcement affects Baxter’s NDA for ondansetron injection in 32 mg/50 ml single IV doses and Teva, Hospira, Bedford Labs and Claris Lifesciences ANDAs for ondansetron HCl and dextrose in 32 mg single IV doses. The drugmakers requested the withdrawal, waiving their right to a hearing.

Ondansetron was originally marketed by GlaxoSmithKline under the brand name Zofran to treat nausea and vomiting associated with chemotherapy. After GSK conducted a study confirming the safety risk, the FDA began working with manufacturers of all 32 mg, single IV dose ondansetron products to have them removed from the market.

Baxter notified the FDA on Sept. 5, 2012, that it was discontinuing the product. An updated safety communication alerted healthcare professionals of the withdrawals.

The FDA has also removed the products from the Orange Book and won’t accept or approve any future products that refer to ondansetron 32 mg.

The actions don’t affect other dosages and formulations of ondansetron.

Read the Federal Register notice on ondansetron at www.fdanews.com/06-10-15-Ondansetron.pdf. The notice on the NDA and ANDA withdrawals is at www.fdanews.com/06-10-15-NDAS.pdf. — Kellen Owings