Hikma Victoza Generic Approved by FDA

FDA has approved Hikma Pharmaceuticals USA’s generic glucagon-like peptide-1 receptor agonist that references Novo Nordisk’s Victoza (liraglutide injection) 18 milligram/3 milliliter. An agency statement says the drug is indicated to improve glycemic control in adults and pediatric patients aged 10 and older with Type 2 diabetes as an adjunct to diet and exercise. It is the first generic approved that references Victoza.

The notice says the generic’s labeling includes a Boxed Warning about the increased risk of thyroid C-cell tumors. It also has Warnings about pancreatitis, liraglutide pen sharing, hypoglycemia when used in conjunction with certain other drugs, renal impairment or kidney failure, hypersensitivity, and acute gallbladder disease.

The most common side effects reported in liraglutide injection clinical trials included nausea, diarrhea, vomiting, decreased appetite, dyspepsia, and constipation, FDA says.