Public health agency the US Food and Drug Administration announced on Monday that it authorised the first generic of glucagon for injection USP in 1 mg/vial in an emergency kit for the treatment of severe hypoglycemia (very low blood sugar), which may occur in patients with diabetes mellitus.
The agency granted approval of generic glucagon for injection to Amphastar Pharmaceuticals Inc of Rancho Cucamonga, California.
According to the agency, the first generic glucagon for injection USP in 1 mg/vial is also indicated as a diagnostic aid in the radiologic examination of the stomach, duodenum, small bowel and colon. Severe hypoglycemia occurs when a patient's blood sugar falls to a level where he or she becomes confused or unconscious, or suffers from other symptoms that require assistance from another person to treat.
In addition, the generic glucagon for injection is a synthetic version of human glucagon. Glucagon is a hormone that causes the liver to quickly increase blood sugar levels. This hormone slows down movement of the gastrointestinal tract, concluded the agency.
European Medicines Agency recommends approval of Alvotech's biosimilar to Eylea
Gan & Lee presents trial results for novel diabetes therapies at ADA's 85th Scientific Sessions
TME Pharma and SERI partner to advance NOX-E36 in ophthalmology through option framework agreement
Innovent reports first participant dosed in new Phase 3 trial of mazdutide in China
Vivoryon Therapeutics presents positive meta-analysis data for varoglutamstat
Camurus and Lilly agree licensing deal for FluidCrystal incretins
Genprex signs new research agreement with University of Pittsburgh to advance diabetes gene therapy