Aug 6 2012
Mylan Inc. (Nasdaq: MYL) today announced that its business Mylan Institutional has received final approval from the U.S. 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 anesthesia. Etomidate Injection USP, 2 mg/mL, in all product presentations has faced recent shortages in the U.S. market.
Etomidate Injection USP, 2 mg/mL, packaged in 20 mL vials, had U.S. 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 Dec. 31, 2011, according to IMS Health.
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