Mylan Launches Generic Precedex Sedative as Hospira Sues FDA

Mylan, Inc, today announced it has launched dexmedetomidine hydrochloride injection, a therapeutically equivalent version of Precedex, while Hospira, Inc, has filed a lawsuit to challenge the generic approval.

According to Hospira, the FDA has approved abbreviated new-drug applications for generic versions of its proprietary sedative and “appears poised to grant additional generic applications” based on the agency’s decision on Monday concerning potential label carve-outs proposed by Mylan and other pharmaceutical manufacturers that had filed for a generic form of the drug, according to the Wall Street Journal.

Dexmedetomidine hydrochloride, which is dosed as 100 mcg (base)/mL and packaged in 200 mcg (base)/2 ml single-dose vials, is indicated to sedate patients prior to and/or during surgery and other procedures. Mylan has begun shipping the product immediately, while Hospira has filed a lawsuit in the United States District Court for the District of Maryland, challenging the FDA’s decision.

In a press release, Mylan CEO Heather Bresch said the generic product launch is “another of a number of key approvals that had been pending with (the) FDA (that) 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,” Bresch added.

The FDA’s approval of Mylan’s dexmedetomidine hydrochloride injection closely follows a key approval of the pharmaceutical manufacturer’s generic version of Genentech’s Xeloda tablets, which are indicated as monotherapy, adjuvant therapy, and combination therapy for certain types of breast, colon, and colorectal cancers. Currently, Mylan has 295 ANDAs pending approval, according to IMS Health.

IMS Health also reported that dexmedetomidine hydrochloride had US sales of approximately $156.2 million for the 12 months ending June 30, 2014, while capecitabine tablets had US sales of approximately $773.8 million in the same period.