Jentadueto XR Approved for the Treatment of Type II Diabetes
May 31, 2016 – The U.S. Food and Drug Administration (FDA) approved Jentadueto® XR (linagliptin/metformin e.r.). Jentadueto XR, manufactured by Boehringer Ingelheim and Eli Lilly, is approved for use in adult patients with type II diabetes where treatment with both linagliptin and extended-release metformin is appropriate. The product is a once-daily fixed dose combination of the dipeptidyl peptidase-4 (DDP-4) inhibitor, Tradjenta (linagliptin), and extended-release metformin. Jentadueto XR will be available in two strengths (linagliptin/metformin e.r.) 5mg/1000mg and 2.5mg/1000mg and is anticipated to be released in mid to late July.
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.