FDAnews Drug Daily Bulletin

CDER is looking to elevate the Office of Generic Drugs (OGD) into a “super” office, a move necessitated by the recent passage of the Generic Drug User Fee Amendments (GDUFA) and a heightened public focus on generic medicines, Center Director Janet Woodcock said Friday.

British drugmaker A Nelson has been cited in an FDA warning letter after an inspection found glass fragments in a batch of the company’s Clikpak drug vials.

Medivation and Astellas expect their oral prostate cancer treatment Xtandi will be available mid-September, following an Aug. 31 FDA approval.

A $6.4 billion accord for U.S. drug and device reviews is set to unravel just three months after taking effect as lawmakers squabble over budget cutbacks.

Drugmakers Salix Pharmaceuticals and Dr. Falk Pharma GmbH on Friday hit rival Lupin and its pharmaceutical unit with a patent suit in Delaware federal court seeking to stop Lupin from marketing a generic version of Salix’s ulcerative colitis drug Apriso.

In Africa, malaria deaths have been cut by 33 percent in the last decade, and the recent discovery of a potential malaria treatment by University of Cape Town researchers has created a buzz in the global health community.

The first large and comprehensive study of the genetics of a common lung cancer has found that more than half the tumors from that cancer have mutations that might be treated by new drugs that are already in the pipeline or that could be easily developed.

The Irish drugmaker Jazz Pharmaceuticals is selling its women’s health business to specialty pharmaceutical company Meda for $95 million in cash so that it can concentrate on its core products.

The Irish department of Health and drug manufacturers are close to a deal that could cut the state’s drugs bill by up to $511 million. Although some details remain to be ironed out, an agreement cutting the annual cost of drugs for the next three or four years is expected to be struck next week.