The drug is indicated for use in adults to manage pain, by taking it alone or in combination with opioid analgesics.
Hospira senior vice-president and chief scientific officer Sumant Ramachandra said: "In today’s healthcare environment, pain management and patient satisfaction are important to hospitals.
"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 was based on two double-blind, placebo and active-controlled, multiple-dose clinical trials of adult patients with postoperative pain and intravenous (IV) morphine was permitted as rescue medication for pain management in both trials.
Around 245 patients were treated with Dyloject in the first trial and about 277 patients in the second study.
According to the company, efficacy was demonstrated by a reduction in pain intensity as measured by the sum of the pain intensity differences in patients receiving Dyloject as compared to placebo.
Image: Hospira has received FDA approval from Dyloject Injection. Photo: courtesy of Baitong333/ FreeDigitalPhotos.net.