The FDA approved the first generic version of Victoza (liraglutide injection) for adults and children age 10 years or more with type 2 diabetes. Hikma Pharmaceuticals USA Inc manufactured that glucagon-like peptide-1 receptor agonist, aiming to improve glycemic control as an adjunct to diet along with exercise.

Approval Data:

• The generic liraglutide injection (18 mg/3 mL) offers an alternative to the brand version Victoza.

• This is the second generic approval in this class, after generic approval referencing Byetta (exenatide) last month.

FDA Priority for Drug Shortages:

• In light of shortages of liraglutide and other GLP-1 drugs, the FDA expedited this approval to enhance patient access to more affordable treatment options.

Mechanism and Use:

• Liraglutide increases blood glucose by mimicking the action of the GLP-1 hormone in the pancreas, correcting a deficit that defines type 2 diabetics.

• The medication is a key part of the treatment of type 2 diabetes, a chronic condition that affects more than 38 million Americans.

Safety and Precautions:

• Boxed Warning: Patients with a history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 should not receive liraglutide.

• Other side effects include pancreatitis, hypoglycemia if used in combination with insulin or sulfonylurea, gallbladder disease, and renal impairment.

• Side effects that occur commonly: Nausea, diarrhea, vomiting, loss of appetite, dyspepsia, and constipation.

FDA Action Plan:

• The FDA Drug Competition Action Plan promotes increased generic competition for complex drugs such as liraglutide.

• Guidance for Industry and the pre-ANDA program is focused on making the drug development and regulatory processes easier for generic drugs.

Manufacturer:

• Hikma Pharmaceuticals USA Inc. was approved. Product availability information is available from the manufacturer.

This approval marks an important step toward dealing with rising type 2 diabetes incidence, especially among the young population. The FDA plans to cut the cost of treatment and increase access for millions of patients by providing them with generic alternatives.