Mylan, announced that its business Mylan Institutional has launched dexmedetomidine hydrochloride injection, 100 mcg (base)/mL, packaged in 200 mcg (base)/2 mL single-dose vials, which is therapeutically equivalent to Hospira's Precedex.
Mylan received final approval from the US Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for the sedation of non-intubated patients prior to and/or during surgical and other procedures, and began shipping immediately.
Mylan chief executive officer, Heather Bresch commented: "Mylan's launch of a therapeutically equivalent version of Precedex injection, another of a number of key approvals that had been pending with FDA, represents an important addition to Mylan's injectables portfolio and growing line of products in the anesthesia and pain management category. As we continue to bring a high quality, reliable supply of injectable products to the US market, Mylan looks forward to delivering on its promise of providing quality medicine and service excellence in the increasingly important institutional space."
Dexmedetomidine hydrochloride iInjection, 100 mcg (base)/mL, packaged in 200 mcg (base)/2 mL single-dose vials, had US sales of approximately $156.2 million for the 12 months ending June 30, 2014, according to IMS Health.
Currently, Mylan has 295 ANDAs pending FDA approval representing $105.8 billion in annual sales, according to IMS Health. Forty-three of these pending ANDAs are potential first-to-file opportunities, representing $25.0 billion in annual brand sales, for the 12 months ending December 31, 2013, according to IMS Health.