Diabetes Type 2 Treatment Adlyxin Approved
July 28, 2016 – The FDA approved Adlyxin™ (lixisenatide) by Sanofi. The drug is a glucagon-like peptide-1 (GLP-1) agonist for treating adults with type 2 diabetes. Adlyxin is a self-administered once-daily subcutaneous injection and will be available in 50mcg/mL (green) and 100mcg/mL (burgundy) prefilled pens. The pens are designed to deliver fourteen doses of 10mcg and 20mcg per dose, respectively. The initial dose of Adlyxin is 10mcg once daily for 14 days and then increased to 20mcg daily.
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 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.