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FDA is alerting patients, caregivers and health care professionals to immediately inspect certain lots of Amneal and Impax epinephrine auto-injector 0.3 mg to ensure the yellow “stop collar” in the device is present.
As a result of the sale, Impax expects to record a pre-tax impairment charge of approximately $70.0 to $80.0 million in the fourth quarter of this year
Impax announced it has received an AB therapeutic equivalent rating and final U.S. Food and Drug Administration (FDA) approval on its Abbreviated New Drug Application for a generic version of Concerta (methylphenidate hydrochloride) Extended-Release table