Hospira gets US FDA nod for Dyloject injection

01 January 2015 | News | By BioSpectrum Bureau

Hospira gets US FDA nod for Dyloject injection

Dyloject is indicated for use in adults for the management of mild to moderate pain

Dyloject is indicated for use in adults for the management of mild to moderate pain

The US Food and Drug Administration (US FDA) has approved Hospira's Dyloject (diclofenac sodium) injection, a proprietary nonsteroidal anti-inflammatory drug (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.

"In today's healthcare environment, pain management and patient satisfaction are important to hospitals. As a result, various medical organisations are now recommending a multi-modal approach to pain control in an effort to minimise the use of opioids", said Mr Sumant Ramachandra, senior vice president and chief scientific officer, Hospira.

"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," he added.

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 (IV) morphine was permitted as rescue medication for pain management.

.

 

Comments

× Your session has been expired. Please click here to Sign-in or Sign-up
   New User? Create Account