March 02, 2010
The FDA has approved Exalgo (hydromorphone HCl extended-release tablets, from Covidien) for the management of moderate to severe pain in opioid-tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time.
February 10, 2010
QRxPharma Limited announced initiation of a second Phase 3 registration trial (Study 009) to evaluate its MoxDuo IR (morphine and oxycodone) product for the management of moderate to severe pain in patients who have undergone total knee replacement surgery.
January 27, 2010
Roxane Laboratories announced that the New Drug Application (NDA) for high concentrate morphine sulfate oral solution 100mg/5mL (20mg/mL) has been approved by the FDA.
January 26, 2010
FDA notified healthcare professionals of a Class I recall of Exel/Exelint Huber needles, Exel/Exelint Huber Infusion Sets, and Exel/Exelint "Securetouch+" Safety Huber Infusion Sets due to 'coring,' the cutting or dislodging of silicone cores or slivers from the ports into which they are inserted).
December 02, 2009
Johnson & Johnson and its subsidiaries, PriCara and Ortho-McNeil-Janssen, announced that they have submitted a New Drug Application (NDA) to the FDA for tapentadol extended release (ER) tablets for the management of moderate to severe chronic pain in patients ≥18 years of age.