Synjardy XR Approved
December 12, 2016 – The U.S. FDA approved Synjardy® XR (empagliflozin/metformin extended-release) tablets, jointly marketed by Eli Lilly and Boehringer Ingelheim. A long-acting combination, it is taken once daily to improve glycemic (blood sugar) control for adults with type 2 diabetes mellitus when treatment with both empagliflozin and metformin is appropriate. Empagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor, a drug class that blocks reabsorption of glucose in the kidneys. Metformin lowers glucose production and raises insulin utilization. As with all drug products that include metformin, Synjardy XR carries a boxed warning and has a medication guide about the possibility that it may cause lactic acidosis – a rare, but potentially dangerous, accumulation of acids in the body.
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.