FDA approves Mylan’s Precedex generic

PITTSBURGH — The Food and Drug Administration has approved Mylan Institutional’s application for its dexmedetomidine hydrochloride injection, the company announced Tuesday. The intravenous sedative is a generic version of Precedex, which is manufactured by Hospira. 

“Mylan's launch of a therapeutically equivalent version of Precedex Injection … represents an important addition to Mylan's injectables portfolio and growing line of products in the anesthesia and pain management category,” Mylan CEO Heather Bresch said. “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."

The company began shipping the single-dose vials immediately. According to IMS Health, the injection’s sales were at about $156 million by the end of June. Mylan currently has almost 300 Abbreviated New Drug Applications before the FDA for generic products.