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.
October 14, 2009
The FDA has launched a Web page for consumers with information on how to dispose of certain drugs, including several high-potency opioids and other selected controlled substances.
October 14, 2009
The FDA has warned four companies that they must stop marketing unapproved codeine sulfate tablets, an opioid analgesic indicated for the treatment of pain.
October 08, 2009
BioDelivery Sciences announced that Onsolis (fentanyl buccal soluble film) will be made available by Meda next week for the management of breakthrough pain in patients ≥18 years of age with cancer who are already receiving and are tolerant to opioid therapy for their underlying persistent cancer pain.
September 23, 2009
Covidien, Neuromed Pharmaceuticals, and CombinatoRx announced that the FDA has heard presentations and public testimony and discussed the New Drug Application (NDA) submitted for Exalgo (hydromorphone HCl) extended release tablets 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.