Fusilev Available As a Generic
April 24, 2015 - The U.S. Food and Drug Administration (FDA) approved Fusilev, manufactured by Sandoz. Fusilev is a ready-to-use levoleucovorin injection, a non A-rated alternative to Spectrum Pharmaceutical’s Fusilev solution for intravenous use. Levoleucovorin reverses toxic effects following treatment with high doses of methotrexate for bone cancer patients. It also has an indication along with 5-fluorouracil as palliative therapy of advanced metastatic colorectal cancer.
Sandoz launched levoleucovorin immediately upon approval. According to IMS Health, for the 12 months that ended on February 28, 2015, Fusilev sales totaled $185 million in the U.S.
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 regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular 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 a 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.