August 8, 2013

The Supreme Court usually has a lot on its plate in any given year, but this year's term included a pretty big case for the pharmaceutical industry: the Federal Trade Commission v. Actavis, which concerned legal settlements between branded and generic drug makers that often occur when the latter attempts to market a generic drug before the former's patents have expired.

August 8, 2013

Keryx Biopharmaceuticals announced the submission of a new drug application to the Food and Drug Administration seeking approval for the marketing and sale of Zerenex (ferric citrate coordination complex), the company's drug candidate for the treatment of elevated serum phosphorus levels, or hyperphosphatemia, in patients with chronic kidney disease on dialysis.

August 6, 2013

The Food and Drug Administration has approved a generic heart disease drug made by Lupin, the Indian drug maker said.

July 31, 2013

The Food and Drug Administration has approved a Perrigo generic drug for treating dermatitis, the company said Wednesday.

July 31, 2013

Nearly 450 drugs are under development for treating neurological disorders, according to a report by a drug industry trade group.

July 29, 2013

Actavis hopes to become the first to market a generic drug for treating chronic pain, the company said.

July 29, 2013

Drug maker Pfizer is planning to split its commercial division into three business lines that will separate its branded and generic products, the company said Monday.

July 26, 2013

A federal court has ruled in favor of generic drug maker Sandoz in a case involving a drug for multiple sclerosis, Sandoz said.

July 24, 2013

Canadian regulators have approved two drugs made by GlaxoSmithKline for treating skin cancer.

July 23, 2013

A federal court has ruled that a Mylan lawsuit against GlaxoSmithKline over an antidepressant drug can go to trial.

July 22, 2013

A new bill would exempt user fees paid by drug companies to the Food and Drug Administration — including those of generic drug makers — from the automatic federal budget cuts that went into effect in March, commonly known as the sequester.

July 22, 2013

Decisions on whether to bring new generic drugs to market depend significantly on companies' ability to settle patent lawsuits filed by branded drug companies, according to a new white paper.

July 22, 2013

An announcement Monday by generic drug maker Sandoz gives a glimpse of what could happen in the United States when biosimilars start to become available.

July 19, 2013

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.

July 19, 2013

Perrigo announced the tentative approval for repaglinide tablets, a generic version of Novo Nordisk's Prandin, used to treat Type 2 diabetes.

July 19, 2013

A drug-safety website operated by drug maker Purdue Pharma has won accolades from an international awards program for marketing and communications.

July 18, 2013

The Food and Drug Administration has approved a cholesterol drug made by Par Pharmaceutical Cos., the drug maker said Thursday.

July 17, 2013

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.

July 12, 2013

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.

July 12, 2013

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.

July 11, 2013

Mylan is challenging a patent on a drug used to treat ulcerative proctitis, the generic drug maker said Thursday.

July 9, 2013

Amgen will get rights to a drug for cardiovascular disease approved in the European Union under a new deal with French drug maker Servier, the two companies said.

July 9, 2013

The Food and Drug Administration has approved a generic drug for treating Alzheimer's disease, FDA records showed.

July 9, 2013

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.