FDA Approves Invokamet XR
September 12, 2016 – The US FDA approved Invokamet® XR, (canagliflozin/metformin extended-release) tablets, a once-daily form of Janssen’s Invokamet® (canagliflozin/metformin). Invokamet XR is a fixed-dose combination sodium-glucose co-transporter 2 (SGLT2) inhibitor and extended-release metformin, indicated for the first-line treatment of adults with type 2 diabetes. Tablets will be available in four strengths -- either 50mg or 150mg of canagliflozin, and either 500mg or 1000mg of extended-release metformin. Recommended dosing is two tablets every morning along with breakfast. Metformin may be associated with lactic acidosis, which is an uncommon, but serious condition, therefore labeling for Invokamet XR includes a boxed warning.
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.