Synjardy Approved As Adjunct Treatment for Patients with Type 2 Diabetes
August 27, 2015 – The U.S. Food and Drug Administration (FDA) approved Synjardy (empaglifozin/metformin) as an adjunct to diet modification and exercise to manage blood sugar levels for patients with type 2 diabetes. Jointly developed by Eli Lilly and Boehringer Ingelheim, Synjardy is specifically indicated for adults with unstable blood sugars despite highest tolerated doses of metformin, treatment with metformin and other antidiabetic medications, or therapy with Jardiance (empagliflozin) and metformin as separate tablets. The recommended maximum dose is 12.5mg empagliflozin and 1000mg metformin to be taken twice a day. There is currently no launch date or pricing information for Synjardy. Synjardy will carry a boxed warning about the risk of lactic acidosis when using it because it contains metformin.
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- 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
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*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.