Food and Drug Administration Commissioner Margaret Hamburg defended the agency’s decision to approve the pure hydrocodone drug Zohydro ER (extended release). At a Senate hearing, Hamburg said, “If appropriately used, it serves an important and unique niche with respect to pain medication and it meets the standards for safety and efficacy.”
The attorneys general from 28 states are asking the Food and Drug Administration (FDA) to reassess its decision to approve Zohydro ER (extended release), a pure form of the painkiller hydrocodone. Earlier this month, four U.S. senators told the FDA Commissioner Margaret Hamburg they disagree with the agency’s decision to approve the drug.
Last June, I testified before a Reference Committee at the annual meeting of the American Medical Association, explaining a resolution that American Society of Addiction Medicine had brought forward to encourage the Food and Drug Administration to reschedule hydrocodone combination products from Schedule III to Schedule II. I expected there to be few others testifying. I wasn’t at all ready for the long line of individuals standing at the “con” microphone, ready to speak against the resolution, says Dr. Stuart Gitlow, ASAM President.
Scientists at the Food and Drug Administration have found an amphetamine-like compound in nine dietary supplements, USA Today reports. The compound, beta-methylphenethylamine, appears to have never been tested for safety on humans.
A number of states are making their own decisions about regulating e-cigarettes, as they await the Food and Drug Administration’s rules about the devices. Four states have included e-cigarettes in indoor smoking bans, and more are considering following suit.
The Food and Drug Administration on Friday approved the first pure hydrocodone drug in the United States. The drug, Zohydro ER (extended release), was approved for patients with pain that requires daily, around-the-clock, long-term treatment that cannot be treated with other drugs.
Business and patient groups waged a costly lobbying campaign against tighter prescribing regulations for hydrocodone products for many years, according to The New York Times. Last week, the Food and Drug Administration recommended tighter restrictions for products containing hydrocodone and other painkillers such as acetaminophen or aspirin.
The Food and Drug Administration has recommended tighter restrictions for products containing hydrocodone and other painkillers such as acetaminophen or aspirin. These combination products include Vicodin and Lortab.
The Attorneys General of 41 states asked the Food and Drug Administration to issue regulations for e-cigarettes by the end of October. They said they want to ensure e-cigarette companies do not continue to sell or advertise to minors.
The U.S. Food and Drug Administration and the National Institutes of Health will award up to $53 million this fiscal year to create a tobacco research program. Funding over five years could reach $273 million, Reuters reports.
The U.S. Food and Drug Administration has announced safety labeling changes for extended-release and long-acting opioid painkillers. The new labels will call attention to the dangers of abuse and possible death, Reuters reports.
The Food and Drug Administration says menthol-flavored cigarettes raise critical public health questions, and likely pose a greater risk to the health of smokers than non-menthol cigarettes, The Wall Street Journal reports.
In an important step forward for victims of the past predatory marketing practices of Big Tobacco, the Massachusetts Supreme Judicial Court issued last week its decision in Evans v. Lorillard, upholding $35 million in compensatory damages against Lorillard, the makers of mentholated Newport cigarettes.
The U.S. Food and Drug Administration announced Thursday it has shut down 1,677 illegal online pharmacies, CNN reports. The websites sold counterfeit or substandard medications, or sold drugs without appropriate safeguards.
The Food and Drug Administration on Tuesday announced it had authorized the sale of two new cigarette products and rejected four others. It is the first time the agency has exercised its power to regulate cigarettes and other tobacco products since it was given that authority in 2009.
More than a dozen drug companies are working on abuse-resistant painkillers, in the wake of the Food and Drug Administration’s decision last month not to approve any generic versions of the original form of OxyContin.
The new head of the Food and Drug Administration’s (FDA) Center for Tobacco Products, Mitch Zeller, has begun to review the risks of menthol in cigarettes, according to Bloomberg. He is also considering whether to increase the FDA’s authority over e-cigarettes, cigars and other tobacco products.