Hospira Obtains FDA Approval Of Proprietary Analgesic Dyloject Injection

(RTTNews) - Hospira Inc. (HSP) said that it has received approval from the U.S. Food and Drug Administration or FDA for Dyloject (diclofenac sodium) Injection, a proprietary nonsteroidal anti-inflammatory drug or NSAID analgesic.

Dyloject is indicated for use in adults for the management of mild to moderate pain and for the management of moderate to severe pain alone or in combination with opioid analgesics.

Javelin Pharmaceuticals, a wholly-owned subsidiary of Hospira, Inc., is the approved license holder of Dyloject.

During clinical development, 1,156 subjects of both healthy volunteers and patients were exposed to Dyloject in multiple-dose, controlled and open-label studies. Dyloject's approval is based on two double-blind, placebo and active-controlled, multiple-dose clinical trials of adult patients with postoperative pain. In both trials, intravenous (I.V.) morphine was permitted as rescue medication for pain management.

The company warned that non-steroidal anti-inflammatory drugs or NSAIDs may increase the risk of serious cardiovascular or CV thrombotic events, myocardial infarction, and stroke, which can be fatal. Risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. Dyloject is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft or CABG surgery.