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In March 2018, insulin glargine (Semglee) was approved for medical use in the European Union. [28] In July 2021, insulin glargine-yfgn (Semglee) was approved for medical use in the United States as the first interchangeable biosimilar of Lantus. [12] The FDA granted approval of Semglee to Mylan Pharmaceuticals Inc. [12]
In July 2021, the FDA approved insulin glargine-yfgn (Semglee), a biosimilar product that contains the long acting analog insulin glargine. [103] Insulin glargine-yfgn is interchangeable and less expensive than the reference product, insulin glargine (Lantus), which had been approved in 2000. [104] The FDA requires that new insulin products are ...
Insulin glargine/lixisenatide, sold under the brand name Soliqua among others, is a fixed-dose combination medication that combines insulin glargine and lixisenatide and is used to treat diabetes. The most common side effects include hypoglycemia (low blood glucose), diarrhea, vomiting and nausea (feeling sick).
Mylan Pharmaceuticals recalled one batch of Insulin Glargine Injection, 100 units/mL (U-100), 3 mL prefilled pens, which are sold in cartons of five. Some pens might be missing their labels.
Now, the maker of a once-weekly insulin injection is seeking approval from the US Food and Drug Administration, but a committee of agency advisers is divided on whether the benefits of the product ...
The comments come after the FDA's staff on Wednesday flagged the risk of low blood sugar in type 1 diabetes patients, who are more insulin-dependent, and the lack of clinical data to support Novo ...