: ' FDA'

Attorneys General Ask for New Opioids Warning

By Richard Lenti Dozens of state attorney generals are asking the Food and Drug Administration to issue a “black box” warning about the danger of pregnant women using opioid painkillers. A recent study found that opioids [...]

No Decision on Zohydro Until Summer

By Pat Anson, Editor The Food and Drug Administration has notified Zogenix Inc. (NASDAQ: ZGNX) that it won’t reach a final decision on the company’s powerful new painkiller, Zohydro, until this summer. “To our knowledge this [...]

FDA Delays Approval of Suboxone Implant

By Pat Anson, Editor Titan Pharmaceuticals, Inc. (OTCC: TTNP) has announced that it received a letter from the Food and Drug Administration delaying approval for an implantable version of buprenorphine, an opioid addiction treatment drug more [...]

FDA May Change Painkiller Labeling

By Pat Anson, Editor The head of the Food and Drug Administration says her agency is considering a change in the labeling requirements for opioid painkillers – a move that many pain patients fear will make [...]

DEA Wants FDA to Restrict Painkillers

By Pat Anson, Editor In a highly unusual move for a federal agency, the U.S. Drug Enforcement Agency publicly urged the Food and Drug Administration to change the labeling requirements for opioid painkillers. In a March [...]

Lawmakers Urge FDA to Restrict Vicodin

By Pat Anson, Editor A bipartisan group of congressmen is demanding the Food and Drug Administration “act without delay” by restricting access to Vicodin and other hydrocodone products, the most widely used and abused narcotic painkiller [...]

Rescheduling Vicodin Will Hurt Pain Patients

By Mark Maginn, Columnist People living with pain sustained another jolt last week at the hands of a Food and Drug Administration advisory panel. The panel voted 19 to 10 to recommend that Vicodin and other [...]

FDA Panel Backs Tighter Controls on Vicodin

By Pat Anson, Editor An advisory panel for the Food and Drug Administration has recommended tighter controls on Vicodin and other hydrocodone products, the most widely used and abused narcotic painkiller in the U.S. The FDA [...]

FDA Approves New Migraine Patch

By Pat Anson, Editor Millions of Americans who suffer from migraine will soon have a new treatment option – one that doesn’t come in a bottle or pill. It’s a battery powered patch that acts as [...]

FDA Issues Tamper Resistant Guidelines

By Richard Lenti Calling the abuse of prescription pain medications  “a major health challenge for our nation,” the Food and Drug Administration has issued a draft guidance document designed to help drug companies develop opioid drugs [...]