Aloxi 0.25mg/5mL Generics Launched
March 23, 2018 – The U.S. FDA has approved Teva Pharmaceuticals’ generic for Eisai/Helsinn’s Aloxi® (palonosetron) injection for intravenous use, 0.25mg/5mL. The drug is indicated to prevent nausea in patients undergoing surgery, as well as patients undergoing chemotherapy treatment for cancer. Teva launched the new generic immediately upon approval. Dr. Reddy’s and Cipla launched their own generics for Aloxi 0.25mg/5mL shortly after Teva’s version received FDA approval. Cipla’s version is considered an authorized generic.
A 5HT3 receptor antagonist, palonosetron works by blocking 5HT3 receptors in the body. This prevents serotonin from binding to the receptors and triggering nausea. Palonosetron can be used in patients as young as one month old. Recommended dosing is based on age, weight, and indication.
Global sales of Aloxi 0.25mg/5mL reached an estimated $452 million in 2017, according to IQVIA. Aloxi 0.075mg/1.5mL remains brand only.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call
1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.