FDA lifts import restriction on Hospira as it aims to reinvigorate its infusion pumps

Hospira ($HSP) vowed to cut old product lines, address its production problems and invigorate innovation in its medical devices business as part of a grand plan revealed on May 1, 2013. Now it's making some progress as it said the FDA had lifted an import alert that had prohibited import of infusion pump devices manufactured in its Costa Rica plant.

Now the company will be able to sell those devices, including its Plum A+ and LifeCare PCA infusion pumps, in the U.S. The company has said it will immediately resume importation.

Hospira has said it hopes to complete all the aspects of its plan to improve its devices business during the second half of 2015. The company received a series of warning letters from the FDA regarding its medical device production facilities from 2010 to 2013, and has since been on the road to trying to repair that damage.

During the first three quarters of 2014, the company, which is primarily devoted to injectable drugs, brought in 19% of its $3.3 billion in net sales through its Medication Management business that includes infusion pumps as well as related software and services.

The company has said it expects to take about $300 to $350 million in pre-tax charges related to implementing its device strategy which consists of modernizing its installed base via retirement and replacement programs, improving production quality systems and processes and developing next generation technology like its Plum 360 and SapphirePlus pumps.

In addition to the lifted import restriction, Hospira said it expects to launch both of these next-generation pumps this year. Hospira partner Q Core Medical recently received FDA clearance for SapphirePlus, while Plum 360 is under review for FDA clearance.

The company also recently expanded its partnership with Q Core Medical to develop new infusion pumps and it hopes the relationship will result in new infusion pumps including those for general infusion, patient-controlled analgesia (PCA), syringe and ambulatory use.

Hospira seems to have been successful thus far in its plan to regain investor trust. It's up almost 50% in the last year and gained 1% in early trading on the news.

- here is the release

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