Mylan Inc. has announced that its business 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. This product is the generic version of Hospira's Amidate injection, which is indicated by intravenous injection for the induction of general anaesthesia. Etomidate injection USP, 2 mg/mL, in all product presentations has faced recent shortages in the US market.
Etomidate injection USP, 2 mg/mL, packaged in 20 mL vials, had US sales of approximately $6.58 million for the 12 months ending March 31, 2012, according to IMS Health. Mylan has begun shipping the 20 mL vial presentation of this product in packs of 10.
Currently, Mylan has 169 ANDAs pending FDA approval representing $83 billion in annual sales, according to IMS Health. Thirty-five of these pending ANDAs are potential first-to-file opportunities, representing $25.1 billion in annual brand sales, for the 12 months ending December 31, 2011, according to IMS Health.
Mylan Institutional, part of Mylan Inc., is a customer-focused business providing a differentiated basket of pharmaceutical products and services, including a broad range of injectable products and SKU's in unit dose, unit-of-use, and automation-ready package formats, to institutional customers, which include group purchasing organizations, wholesalers, hospitals, surgical and radiology services, home infusion service providers, long-term care facilities, correctional facilities, specialty pharmacies, veterinary clinics and retail outlets.