Legislation proposed in the House of Representatives would speed up Food and Drug Administration approval of knock-off versions of vaccines and other biologics while requiring the agency to conduct more inspections of drug factories overseas, according to published reports.
Faced with the possibility of a critical cutoff in funding for the Food and Drug Administration, Congress moved in late May to reauthorize the Prescription Drug User Fee Act that provides the bulk of the agency’s resources for new-drug review and approval.
The Food and Drug Administration has approved a branded acne drug made by Ranbaxy Labs, the drug maker said. Ranbaxy announced the FDA approval of Absorica (isotretinoin), a drug for treating severe recalcitrant nodular acne.
While the picture of a new Rx-to-OTC switch paradigm is being painted with a broad stroke brush, already there are two divergent pathways emerging around what that new paradigm landscape might look like.
The U.S. Court of Appeals for the Federal Circuit ruled in favor of Watson Pharmaceuticals during patent litigation concerning the drug maker's abbreviated new drug application for an overactive bladder treatment.