According to the Wall Street Journal, the Food and Drug Administration Commissioner, Andrew von Eschenbach, will leave the agency on Jan. 20, the day Barack Obama becomes president. Steve Nissen, Joshua Sharfstein and Janet Woodcock, named as potential candidates.

The Food and Drug Administration posted on its website a Warning Letter sent to Shionogi & Co. about misleading the public with exaggerated claims for the antibiotic Cedax (ceftibuten). According to the FDA, Shinogi claim that the drug had excellent tolerability.

In a regulatory filing with the Securities and Exchange Commission, Biotech Amylin Pharmaceuticals reported that the U.S. Food and Drug Administration (FDA) rejected data for the experimental exenatide LAR version of its diabetes drug Byetta, due to manufacturing differences between the drug made at Amylin facilities and that produced at partner Alkermes´ factory. Further details

Cephalon Inc announced that the Food and Drug Administration (FDA) will not allow it to market its painkiller Fentora (fentanyl) for other than cancer patients until the company implements improvements to the opioid drug´s risk management program. Further details.

Vanda Pharmaceuticals reported it plans to respond to the Food and Drug Administration (FDA) rejection of its experimental schizophrenia drug Iloperidone. The agency included recommending additional studies in the rejection of the application.

The change in how the U.S. health regulating agency will now respond to drug applications has the market and industry wondering and speculating on its effects: This week the Food and Drug Administration (FDA) will be answering applications with a “complete response” letter, replacing the former “approvable” and “not approvable” letters, both sent when the FDA required further information on the drug. FDA officials say the new format will help make their decisions more consistent. Further details.

Centocor, Inc. announced that the U.S. Food and Drug Administration (FDA) has extended the review timeline for the Biologic License Application for ustekinumab, its subcutaneous biologic therapy, by three months to December 2008. Centacor filed its application late in 2007, and seeks approval to market ustekinumab for the treatment of adult patients with chronic moderate to severe plaque psoriasis. Further details.

The Food and Drug Administration (FDA) announced that Pfizer Inc and Ligand Pharmaceuticals´ new drug application for their experimental treatment for osteoporosis Fablyn will be examined by its panel of reproductive drug experts in September.

An upcoming Food and Drug Administration (FDA) advisory committee will be focusing on general generic-drug issues, not specifically on ViroPharma Inc.’s only marketed treatment, Vancocin, for gastrointestinal-tract infections, the company reported. The FDA does not yet have a system in place to test and approve generic versions of biotech drugs.

The Federal and Drug Administration has lifted the clinical hold over Adolor Corporation and GlaxoSmithKlinePlc’s drug Enterg for treatment in opioid bowel dysfunction, although company is to submit a protocol for an additional study in this indication."

Discovery Labs shares drop 19 percent after the biotech firm put off its response to the FDA’s May 1 Approvable Letter expressing concerns over its experimental drug Surfaxin for the prevention of RDS in premature infants until September

In a new proposal designed by U.S. health regulators, to be submitted to the public for comment, prescription drugs would carry new warnings about risks for women who are pregnant or breastfeeding, announced Food and Drug Administration (FDA) officials. On average, 6 million pregnant women in the U.S. take three to five prescription drugs, and the current system showing the level of risk is out of date. Further details.

Glaxo’s experimental oral platelet growth factor therapy, known as Promacta, does not reduce or prevent bleeding any better than placebo, according to a FDA reviewer. The reviewer evaluated data provided in the NDA submission for Promacta as a short-term treatment of chronic idiopathic thrombocytopenic purpura (ITP)

French drugs group Ipsen and its U.S. partner Medicis announced the Food and Drug Administration (FDA) has agreed to consider the U.S. marketing of Reloxin, their competitor to Allergan´s blockbuster Botox. The two companies filed for an application in March.

Biotech company Geron Corp reported it had received a verbal notice from the Food and Drug Administration (FDA) saying the U.S. health regulators had placed a clinical hold on Geron’s experimental new drug submission for GRNOPC1, a cell therapy for spinal cord injury. No letter had yet been received explaining the decision, stated the company.

The FDA is under mounting pressure to do a better job of monitoring and regulating drugs and medical devices. The federal health agency announced it plans to hire more than 1,300 chemists, biologists, medical officers among other staff members by October as part of a major facelift. A panel of ouside advisers said the FDA needs $375 million next year

Wyeth´s unit, Wyeth Pharmaceuticals, said it is withdrawing its application for European marketing authorization for its antibiotic Tygacil as a treatment for community-acquired pneumonia (CAP)