Toujeo Approved for Diabetes
February 25, 2015 - The U.S. Food and Drug Administration (FDA) approved Toujeo (insulin glargine injection, 300 U/mL) manufactured by Sanofi. Toujeo is a once a day long-acting basal insulin to improve blood glucose control in adults with type 1 or type 2 diabetes mellitus. The dose of Toujeo is individualized to meet the patient’s needs. However, it should be administered at the same time each day as a once-daily subcutaneous injection.
Toujeo will be available in 300 units/mL insulin glargine in a 1.5mL SoloStar disposable prefilled pen and is expected to be available in the U.S. early in the second quarter of 2015. Pricing information is not currently available; however, the cost of Toujeo is expected to be similar to Lantus (insulin glargine injection), also manufactured by Sanodfi which and costs about $3,600 per year.
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.