FDA Cites Manufacturing Problems in Warning Letter to Hospira

Hospira Inc. has received a warning letter from the U.S. Food and Drug Administration (FDA) after agency inspectors found manufacturing problems at two North Carolina manufacturing plants, according to a regulatory filing by the company.

In related news, Hospira, which is a global specialty pharmaceutical and medication delivery company in Lake Forest, Ill., said Monday that it agreed to acquire Javelin Pharmaceuticals Inc. for approximately $145 million ($2.20 per share in cash).

The acquisition of Javelin lets Hospira take advantage of synergies between Javelin’s main product candidate, Dyloject, a post-operative pain management drug currently awaiting FDA approval, and Hospira’s proprietary sedation agent, Precedex, Hospira said.

“Dyloject would broaden Hospira’s pain management portfolio and offers attractive revenue and margin prospects,” said Ron Squarer, chief commercial officer of Hospira. “Dyloject is also a very good fit with Precedex, and further demonstrates Hospira’s strong commitment to the acute-care space.”

Javelin Pharmaceuticals, with headquarters in Cambridge, Mass., focuses on developing new drugs for the pain management market.