June 22, 2012

A drug maker has resubmitted its new drug application to the Food and Drug Administration for an acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.

June 22, 2012

The Food and Drug Administration has issued a complete response letter regarding a supplemental new drug application for a medication developed by Janssen Research and Development.

June 11, 2012

Avanir Pharmaceuticals confirmed that the Food and Drug Administration has accepted the company's investigational new drug application for an Alzheimer's disease drug.

June 7, 2012

Government authorities are working to educate independent pharmacy owners on prescription drug abuse, an independent pharmacy network said.

May 31, 2012

The House Ways and Means Committee on Thursday approved the Restoring Access to Medication Act (H.R. 5842), which would repeal the provision of the Patient Protection and Affordable Care Act that disqualified expenses for over-the-counter drugs as eligible for reimbursement under health savings accounts and flexible spending arrangements without a prescription.

May 29, 2012

The House of Representatives will vote to repeal limitations on the use of tax-advantaged accounts for the purchase of over-the-counter medications as early as June 4, according to a report published online by The Hill, a Washington, D.C.-based political newspaper.

May 22, 2012

Drug maker Apricus Biosciences will receive regulatory guidance from the Food and Drug Administration in July that will contain feedback concerning the drug maker's plans to seek approval for a nail fungus treatment.

May 11, 2012

Despite predictions that consumers in recessionary times would flock to cheaper over-the-counter drugs, the world's over-the-counter drug market grew just 3.5% in the past three years, according a report released by Kalorama Information.

April 24, 2012

Globalization has led to a rapid increase in the drugs and foods arriving on U.S. shores from abroad, a trend that has prompted U.S. regulators to transform their approach.

March 12, 2012

One of the long-term goals of many drug companies has been to win Food and Drug Administration approval for cholesterol-lowering statins as over-the-counter drugs. But it's a goal that has long eluded them due to the agency's concerns about patient safety.

February 23, 2012

The Food and Drug Administration has accepted a new drug application for the treatment of idiopathic Parkinson’s disease.

January 18, 2012

The Food and Drug Administration has provided guidance to Provectus Pharmaceuticals as the drug maker prepares to apply with the agency for approval to start a late-stage clinical trial of a drug for skin cancer, Provectus said Wednesday.

December 20, 2011

Pfizer is seeking approval from the Food and Drug Administration for its investigational treatment of moderately to severely active rheumatoid arthritis.

November 10, 2011

The Food and Drug Administration has accepted a new drug application for a skin cancer treatment developed by Roche.

November 4, 2011

If the ultimate goal of the Affordable Care Act is to save money and expand patient care, then making patients visit their physicians and get prescriptions just to get reimbursed for over-the-counter medications — which wastes money, as well as the time of physicians, a precious commodity when the country is set to have a shortage of them — makes no sense.

October 28, 2011

The Food and Drug Administration has approved a supplemental new drug application related to a drug made by Abbott, the company said.

October 11, 2011

The Food and Drug Administration has approved Mylan’s promethazine hydrochloride tablets, a generic drug for treating allergies, in the 12.5-mg, 25-mg and 50-mg strengths.

September 7, 2011

The Food and Drug Administration has accepted a regulatory approval application for a drug made by Vivus for treating erectile dysfunction.

August 19, 2011

NexMed USA on Thursday received clearance from the Food and Drug Administration to market the company's first over-the-counter antifungal drug, Tolnaftate-D.

July 14, 2011

The National Association of Chain Drug Stores announced on Thursday its support of legislation that seeks to repeal a provision of the Patient Protection and Affordable Care Act, which requires consumers to obtain a prescription to use their flexible spending accounts for over-the-counter medication purchases.

May 23, 2011

Generic drug maker Par has inked a definitive agreement to acquire an India-based developer and manufacturer of generic drugs.

May 19, 2011

Theodore Kaczynski, also known as the Unabomber, allegedly is a suspect in the 1982 Tylenol poisonings in the Chicago area that killed seven people, according to published reports.

May 10, 2011

The branded-drug division of Impax Labs plans to conduct early-stage clinical studies of an investigational drug for restless leg syndrome, the company said Tuesday.

April 21, 2011

GlaxoSmithKline and Valeant last week responded to the Food and Drug Administration's complete response letter for the companies' investigational anti-epileptic drug.