In one of its final official actions of 2020, the FDA approved a generic form of glucagon for emergency treatment of severe hypoglycemia in persons with diabetes mellitus.
The approval, which is the first for a generic of glucagon, is for an injection USP, 1 mg/vial packaged in an emergency kit. The drug is also indicated as a diagnostic aid in the radiologic examination of the stomach, duodenum, small bowel, and colon when diminished intestinal motility would be advantageous, the FDA said in a statement announcing the approval.
“Glucagon for injection has been approved for use in the U.S. for more than 20 years, but until today, there has been no approved generic of this important drug that can save the lives of people who may experience the serious condition of very low blood sugar,” said Sally Choe, PhD, director of the Office of Generic Drugs in FDA’s Center for Drug Evaluation and Research in a prepared statement.
The generic glucagon for injection is a synthetic version of human glucagon. The most common side effects associated with glucagon for injection are nausea and vomiting, a temporary increase in heart rate, and redness and swelling of the injection site.
The FDA granted approval of this generic glucagon for injection to Amphastar Pharmaceuticals, Inc. of Rancho Cucamonga, California.
’The FDA maintains a list of off-patent, off-exclusivity drug products without an approved generic to improve transparency and encourage the development and submission of applications for drugs with limited competition,” the agency explained. “Glucagon is included on this list. The FDA also prioritizes the review of submissions for generic drugs for which there are fewer than three approved generics of the reference listed drug (RLD) and for which there are no blocking patents or exclusivities on the RLD.
“Under the Generic Drug User Fee Amendments (GDUFA), individual companies can meet with the FDA as part of its pre-Abbreviated New Drug Application (ANDA) program to support the development of such complex generic drug products. The FDA also publishes guidance documents describing the steps the FDA recommends companies take to submit complete applications for generic drug products,” the agency added.
Peggy Peck, Editor-in-Chief, BreakingMED™
Cat ID: 12
Topic ID: 76,12,730,12,14,187,192,669,918,925