Labopharm to appeal FDA decision on tramadol
LAVAL, Quebec Labopharm will appeal a decision by the Food and Drug Administration to withhold approval of the company’s once-daily formulation of the painkiller tramadol, according to the Canadian press.
The company will use the FDA’s dispute-resolution process to challenge the agency’s claim that it had not demonstrated that its tramadol product works as indicated. Labopharm had received a second approval letter in May from the FDA for the drug.
FDA’s dispute process permits decisions to be reviewed by various supervisors before proceeding through its chain of command to the Commissioner of Food and Drugs.
FDA to extend review of Tysarbi
The Food and Drug Administration has told Elan and Biogen Idec that they will extend its regulatory review of Tysarbi as a treatment for Crohn’s diseases by up to three months.
Both companies were informed by the FDA that they need additional time to review information regarding Tysarbi’s risk management plan for Crohn’s disease. The three-month period should end on Jan. 13, 2008.
Approximately one million people worldwide have Crohn’s disease, a chronic and progressive inflammatory disease of the gastrointestinal tract, which commonly affects both men and women.
Pozen submits response on migraine drug
CHAPEL HILL, N.C. In response to an approving letter from the FDA, drug developer Pozen Inc. submitted data for its new migraine drug, the company announced Monday.
Pozen and partner GlaxoSmithKline recently met with the FDA to discuss the companies’ future plan for fulfilling the agency’s appeal for the information. Pozen provided the FDA with data from three non-clinical studies for its proposed migraine medication called Trexima.
In addition to the study results submission, the company also provided the FDA with a required routine safety update and revised product labeling. The FDA may take up to six months to review this submission, although the company has requested a 60-day review.
The company also said it will launch a clinical evaluation of the Trexima’s potential of having genotoxicity, any toxic change to DNA’s structure or function.
Results of genotoxic testing will be available for submission to and review by the FDA, if required, during the first quarter of 2008.
“Although we believe that our submission addresses FDA’s concern regarding the genotoxic potential of Trexima, we feel it is prudent to conduct this clinical trial so that we can provide this information without delay, if required,” said Marshall Reese, executive vice president of product development.