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news.Mylan Institutional has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Etomidate Injection USP, 2 mg/mL packaged in 40 mg/20 mL single-use vials.
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The approved product is the generic version of Hospira’s Amidate injection, used as intravenous injection for the induction of general anesthesia.
Mylan at present has 169 ANDAs pending FDA approval.
Mylan Institutional is part of Mylan and is a customer-focused business providing a different pharmaceutical products and services, which include injectable products and SKU’s in unit dose, unit-of-use and automation-ready package formats.