麻豆传媒

The FDA has approved the , a once-daily injectable for improving glycemic control in patients ages 10 and older with type 2 diabetes, used as an adjunct to diet and exercise.

This is the second GLP-1 receptor agonist to have a generic, following last month's (referencing Byetta), a twice-daily injection.

"The FDA supports development of complex generic drugs, such as GLP-1s, by funding research and informing industry through guidance as part of our ongoing efforts to increase access to needed medications," said Iilun Murphy, MD, director of the Office of Generic Drugs in the FDA's Center for Drug Evaluation and Research, in a statement. "Today's approval underscores the FDA's continued commitment to advancing patient access to safe, effective, and high-quality generic drug products."

Generic liraglutide references the 18 mg/3 mL branded product and delivers doses of 0.6 mg, 1.2 mg, or 1.8 mg.

Brand name versions of liraglutide both for diabetes and weight loss (Saxenda) still remain on FDA's shortage list, though they're listed as "available" by maker Novo Nordisk.

"The FDA prioritizes assessment of generic drug applications for drugs in shortage to help improve patient access to these medications," the agency noted.

Generic liraglutide will carry the same warnings on its label, including a boxed warning about the increased risk of thyroid C-cell tumors. "For this reason, patients who have had, or have family members who have ever had medullary thyroid carcinoma should not use liraglutide, nor should patients who have an endocrine system condition called multiple endocrine neoplasia syndrome type 2," the agency warned.

Likewise, patients with a prior serious hypersensitivity reaction to liraglutide or any of the product's components shouldn't use the generic. The label also carries other warnings including for pancreatitis, pen sharing, hypoglycemia when used in conjunction with certain other drugs known to cause hypoglycemia including insulin and sulfonylurea, renal impairment or kidney failure, hypersensitivity, and acute gallbladder disease.

The most common side effects include diarrhea, nausea and vomiting, decreased appetite, dyspepsia, and constipation -- common with the GLP-1 receptor agonist class of drugs.

In order to , the FDA said it's working to clarify regulatory expectations for applicants early in the development process, including through guidance for industry and the .

Earlier this year, a so-called of liraglutide became available in the U.S., which is the approved branded version but marketed without the trade name.

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