Chephalon warns Fentora prescribers about possible adverse effects
FRAZER, Pa. Cephalon has sent letters to healthcare providers warning them to proper actions when selecting patients, dosages, and administration of their narcotic painkiller Fentora.
This comes as a result of deaths and other serious adverse events of people taking the medication. Cephalon has said that the patients were not appropriate candidates for the drug.
According to the FDA’s MedWatch site, “These deaths occurred as a result of improper patient selection (e.g., use in opioid nontolerant patients), improper dosing and/or improper product substitution. The healthcare professional letters provide key points regarding appropriate patient selection, and proper dosing and administration of Fentora (fentanyl buccal tablet) to reduce the risk of respiratory depression.”
GSK flu vaccine facility in Quebec is nearly completed
QUEBEC CITY, Canada GlaxoSmithKline said that it is near completion of its Quebec City manufacturing facility, used to develop the company’s influenza vaccine.
After a two-year—and $199 million—investment to upgrade the manufacturing site, the location will increase the capacity of vaccine doses to 75 million per year, the company said. The expansion has also given way to providing this facility, and existing ones, new equipment and other innovative technologies to assure efficient production.
The company has also doubled the size of its vaccine workforce in Quebec City since January 2006.
“[This] announcement reinforces the key role that both Quebec and Canada play in GSK’s global vaccine business,” said Michel Baijot, vice president of Worldwide Strategic Alliances and Business Development, GlaxoSmithKline Biologicals, the company’s vaccine division. “Through this investment, Quebec and Canada will have an impact on global health by supporting countries in their influenza pandemic planning.”
According to GSK, the company supplies about 75% of the Canadian government’s seasonal flu vaccine purchases and will also provide Canada with a pandemic vaccine in the event of an influenza pandemic.
FDARA attempt to limit citizens petitions not likely to have much effect, expert claims
WASHINGTON According to Richard Silver, senior vice president of Equity Research for Lehman Brothers, the Food and Drug Administration’s Revitalization Act, which included language intended to limit the use of citizen petitions to block approvals of generic drugs, will not stop their use by brand companies, the FDA reported.
“Citizen’s petitions … we do not think they’re going to go away. The backlog continues to grow,” Silver said last week during the Generic Pharmaceutical Association’s Annual Policy Conference in Washington, D.C. “We don’t think the citizen’s reforms will change the behavior of brand companies significantly.”
Two versions of the legislation are currently pending before a conference committee.