Generic rosiglitazone maleate and glimepiride have been approved by the FDA to treat adults with type 2 diabetes. It has been determined to be the equivalent of Avandaryl. The FDA noted that though the latter is listed as a discontinued product in the US, it was not withdrawn for safety/efficacy reasons.

Indications: The generic carries the same indication as the branded medication, as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

Dosage and administration: Do not exceed the maximum recommended daily dose of 8 mg rosiglitazone and 4 mg glimepiride.

Efficacy and safety: In studies involving the brand name drug, treatment resulted in statistically significant improvements in fasting plasma glucose and HbA1c compared with monotherapies.

Side effects/risks: Common adverse reactions reported in clinical trials for the brand name drug were headache, hypoglycemia, and nasopharyngitis.

Citation: ANDA approval letter. Silver Spring, MD: FDA Web site; April 1, 2016. http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/078709Orig1s000ltr.pdf. Accessed April 12, 2016.

Avandaryl [package insert]. Research Triangle Park, NC: GlaxoSmithKline; March 2015. https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Avandaryl/pdf/AVANDARYL-PI-MG.PDF. Accessed April 12, 2016.