Toujeo Max SoloStar Approved
March 27, 2018 – The U.S. FDA has approved Toujeo® (insulin glargine 300 Units/mL) Max SoloStar® long-acting insulin pen, manufactured by Sanofi. Toujeo is indicated to improve glycemic control in adults with diabetes mellitus.
According to the manufacturer’s press release, the Toujeo Max SoloStar pen will hold more units of insulin than any other pen currently available in the U.S. market. Sanofi has stated that the pen may reduce the number of injections required for patients who need higher levels of insulin. The Max SoloStar can deliver up to 160 Units/Ml at each injection. As a result of the pen’s higher capacity, the manufacturer states, patients may need fewer refills, which could save on their out-of-pocket costs, depending on their prescription benefits.
Pricing for the Toujeo Max SoloStar will be the same per unit of insulin as its lower capacity counterpart, the Toujeo SoloStar. Sanofi will offer a savings program for eligible patients, and disease management support through the Toujeo COACH program. Toujeo Max SoloStar is expected to launch during the third quarter of 2018.
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.