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.

August 1, 2013

Sanofi Wednesday evening announced that the Food and Drug Administration's Nonprescription Drugs Advisory Committee voted 10-6 in favor of its switch application of the nasal corticosteroid Nasacort AQ. Two committee members abstained.

July 31, 2013

The Food and Drug Administration has given Lupin Pharmaceuticals tentative approval to two of its products, the company said Wednesday.

July 29, 2013

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

July 23, 2013

The Food and Drug Administration on Tuesday took action to remove from the market illegal products, including some labeled as dietary supplements, that claim to mitigate, treat, cure or prevent diabetes and related complications.

July 23, 2013

The Food and Drug Administration has approved a generic diabetes drug made by Lupin, the company said.

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 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 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 16, 2013

Mylan has launched a generic contraceptive therapy, the drug maker said Tuesday.

July 12, 2013

Actavis is looking to become the first to market a generic drug for epilepsy, the company said.

July 12, 2013

The Food and Drug Administration has approved a new lung cancer drug made by Boehringer Ingelheim, the agency said.

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 9, 2013

A total of 27 members of Congress issued a kind reminder to the Food and Drug Administration that many leaders across Capitol Hill are keeping tabs on New Dietary Ingredient guidance.

July 9, 2013

Mylan has received tentative approval for a generic version of a cholesterol drug made by AstraZeneca, according to Food and Drug Administration records.

July 9, 2013

The Food and Drug Administration has approved a new drug for treating opioid dependence.

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 8, 2013

Impax Labs has appointed Mary Pendergast to its board of directors, the generic drug maker said.

July 2, 2013

The Food and Drug Administration has approved a gel formulation of a foot fungus drug made by Merz Pharmaceuticals, according to published reports.