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.

July 9, 2013

The U.S. healthcare system has saved $25.5 billion over seven years from generic drugs launched under patent settlements between branded and generic drug manufacturers, according to a new study.

July 3, 2013

Drug maker Impax Labs is hoping to become the first to market a generic version of a drug used to treat incontinence and overactive bladder, the company said Wednesday.

July 2, 2013

Sandoz, the generics division of Swiss drug maker Novartis, announced the launch of metronidazole 1% topical gel, calling it the first generic version of Galderma Labs' Metrogel.

July 2, 2013

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.

July 1, 2013

The Food and Drug Administration has declined to approve a sleeping pill made by Merck & Co., citing issues with dosage.

June 27, 2013

Onco360 is joining the limited-distribution network for two newly approved cancer drugs made by GlaxoSmithKline, the specialty pharmacy company said.

June 26, 2013

Teva Pharmaceutical Industries and Mylan have launched generic versions of Pfizer's Viagra in nearly a dozen European countries, the two companies said.

June 25, 2013

The Food and Drug Administration has given special designation to a drug made by Raptor Pharmaceuticals for a rare metabolic disease.

June 25, 2013

Drug makers may be allowed to seek approval for a generic version of an eye drug made by Allergan based on lab tests rather than clinical trials, according to published reports.

June 24, 2013

A White House trade policy leader has been appointed as U.S. Trade Representative.

June 24, 2013

Generic drug makers cannot be held liable if patients suffer harmful side effects after taking their drugs, the Supreme Court has ruled in a 5-4 decision.

June 20, 2013

Pharmaceutical wholesaler H.D. Smith will buy a majority interest in a Cincinnati-based patient assistance, pharmaceutical brand support and reimbursement company.

June 20, 2013

Tris Pharma has hired a former buyer from AmerisourceBergen to head its generic drug business, the company said.