Chephalon finalizes label revisions for Provigil
FRAZER, Pa. Cephalon has finalized its revisions to its label for its drug Provigil, which is used to improve wakefulness in adults with obstructive sleep apnea/hypopnea syndrome, shift work sleep disorder and narcolepsy.
These changes were made necessary to make Provigil’s label consistent with Nuvigil’s label, which was approved, by the Food and Drug Administration in June. Nuvigil is a single isomer formulation of the key ingredient found in Provigil.
The company said it plans a commercial launch of Nuvigil once additional clinical data has been amassed.
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.