United States:
FDA Determines That Glucagon (Glucagon Hydrochloride) Was Not Withdrawn For Reasons Of Safety Or Effectiveness
28 September 2015
Jones Day
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In the September 9, 2015, Federal Register, FDA
published its determination that Glucagon (glucagon hydrochloride)
for injection, equivalent to (EQ) 1 milligram (mg) base/vial and EQ
10 mg base/vial, was not withdrawn from sale for reasons of safety
or effectiveness. This determination will allow FDA to approve
abbreviated new drug applications for glucagon hydrochloride for
injection, EQ 1 mg base/vial and EQ 10 mg base/vial, if all other
legal and regulatory requirements are met.
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