FDA Approves First Generic Glucagon for Injection Kit, 1mg pharmacytimes.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from pharmacytimes.com Daily Mail and Mail on Sunday newspapers.
Managing Editor
The Food and Drug Administration as approved the first generic of a drug used to treat severe hypoglycemia. The agency has approved a generic glucagon for injection, 1 mg, from Amphastar Pharmaceuticals. The generic is a synthetic peptide product that the FDA has deemed to be bioequivalent and thus therapeutically equivalent to Eli Lilly’s Glucagon Emergency Kit for Low Blood Sugar. 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, director of the Office of Generic Drugs in FDA s Center for Drug Evaluation and Research. Today s approval reflects the FDA s continued commitment to advancing patient access to lower-cost, high-quality generic drug products that are as safe and effective as their brand name counterparts. Supporti