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news.Mylan has launched its new dexmedetomidine hydrochoride injection, 100 mcg (base)/mL after receiving the final approval from the US Food and Drug Administration (FDA) for the product’s Abbreviated New Drug Application (ANDA).
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The company has already started shipping the new product, which is the therapeutically equivalent version of Precedex Injection.
Mylan CEO Heather Bresch said: "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 U.S. market, Mylan looks forward to delivering on its promise of providing quality medicine and service excellence in the increasingly important institutional space."
According to IMS Health, the US sales of dexmedetomidine hydrochloride injection, 100 mcg (base)/mL, packed in 200mcg (base)/2 mL Single-dose Vials, reached about $156.2m for the year ending 30 June 2014.
About 295 of Mylan ANDAs are still awaiting approval from the US FDA that represent $105.8bn in annual sales, with 43 of them being potential first-to-file opportunities, signifying $25bn in annual brand sales, for the year ending 31 December 2013.