The Council for Responsible Nutrition announced that Daniel Fabricant, director of the Division of Dietary Supplement Programs at the Food and Drug Administration, will be a keynote speaker at The Conference: CRN’s Annual Symposium for the Dietary Supplement Industry Sept. 18 to 21 in Park City, Utah.
A federal court in New York has dismissed a lawsuit alleging that Mylan infringed four of Teva Pharmaceutical Industries' patents when it sought Food and Drug Administration approval for a multiple sclerosis drug.
The creation of a clear approval pathway for biosimilar drugs remains a daunting task for the Food and Drug Administration, despite the fact that it's prescribed by law through the Patient Protection and Affordable Care Act. But when those lower-priced, generic versions of some staggeringly expensive bioengineered medicines do finally come to market, they're likely to have a profound effect on the nation's outlays for specialty pharmaceuticals.
The Indian generic drug maker announced the approval of repaglinide tablets in the 1-mg and 2-mg strengths, which are used in combination with diet and exercise to improve blood-sugar control in patients with Type 2 diabetes.
The Food and Drug Administration has made a significant dent in its large backlog of generic drug applications thanks to amendments to last year's reauthorization of the Prescription Drug User Fee Act, the agency said.
Sandoz has started a late-stage clinical trial of a biosimilar version of a drug used to treat autoimmune disorders, hoping the results will support its efforts to win regulatory approval in the United States and Europe.