After 5-year delay, FDA approves Hospira's injectable painkiller

Hospira touted the ease of administration of its newly FDA-approved injectable painkiller Dyloject, saying the nonsteroidal anti-inflammatory drug "can be administered more conveniently in a small volume intravenous bolus over 15 seconds as opposed to other injectable nonopioid analgesics that are formulated in large volumes or require dilution prior to administration and typically require an infusion of 15 to 30 minutes to administer the full dose," in a statement announcing the approval.

The drug is indicated for the management of mild to moderate pain and moderate to severe pain alone or in combination with opioids. "Various medical organizations are now recommending a multi-modal approach to pain control in an effort to minimize the use of opioids," said Hospira ($HSP) Chief Scientific Officer Dr. Sumant Ramachandra in the statement. "As a leading supplier of hospital pain management medication, Hospira's Dyloject will be a complementary addition to our existing portfolio of acute-care drugs, providing clinicians an additional non-opioid option that can be administered quickly and conveniently to treat pain."

The approval counts as pain relief for Hospira. The company expected U.S. approval soon after it acquired the then-candidate in 2010 via a takeover of Javelin Pharmaceuticals for about $141 million. But shortly after the deal was announced, Dyloject was pulled in the U.K. due to safety and manufacturing issues, explains Crain's Chicago Business. Hospira then tried to wriggle itself free from the deal, but Javelin sued and the deal closed in July 2010.

Hospira told Crain's that it expected FDA approval "this year" in the January 2013 article.

In the rush to outbid Myriad Pharmaceuticals ($MYGN), which bid about $90 million, Hospira waved off due-diligence investigations, Crain's says. In addition, the failure of Dyloject in Europe also led to a lawsuit from Therabel Pharma N.V., which acquired the painkiller's European rights in 2010.

But with FDA approval now in hand, Dyloject could fill the void left by the expiration of most of the patents protecting Hospira's sedative, Precedex, which accounted for around 11% of the company's annual sales of $4 billion in mid-2014. The FDA granted Mylan ($MYL) approval to sell a generic version of that product in August 2014. Hospira sued the FDA over the generic's labeling soon after the agency approved Mylan's version of the drug, the Wall Street Journal reports.

- read the release
- here is Crain's article
- here is more information from Wall Street Journal

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