January 14, 2011

In consultation with the Food and Drug Administration, McNeil Consumer Healthcare on Friday voluntarily recalled certain lots of Tylenol 8 Hour, Tylenol Arthritis Pain and Tylenol upper respiratory products, as well as certain lots of Benadryl, Sudafed PE and Sinutab products at the wholesale level.

January 14, 2011

Pernix Therapeutics Holdings on Wednesday announced an exclusive co-promotion agreement with ParaPro for a medication to treat head lice.

January 13, 2011

The student chapter of the nation’s oldest national pharmacists’ organization has teamed up with the federal government to launch a new outreach effort for improving medication safety.

January 13, 2011

The Food and Drug Administration is capping the amount of the painkiller acetaminophen in prescription drugs due to the risk of liver toxicity, the agency said Thursday.

January 13, 2011

K-V Pharmaceutical announced Wednesday that the Food and Drug Administration extended its Prescription Drug User Fee Act action date to April 13 for a drug under development for preventing preterm birth.

January 13, 2011

Various companies in the healthcare industry are uncertain about the benefits of the Food and Drug Administration’s risk evaluation and mitigation strategy program, and most think it needs a major overhaul, according to a study by the Tufts University Center for the Study of Drug Development.

January 11, 2011

The Food and Drug Administration has accepted a regulatory approval application for a drug to treat Type 2 diabetes made by Merck, the drug maker said Tuesday.

January 10, 2011

The Food and Drug Administration has approved a new drug for treating pain in cancer patients, the agency said Friday.

January 10, 2011

The Food and Drug Administration declined to approve Endo Pharmaceuticals’ regulatory application for a painkiller designed to thwart drug abusers, Endo said Friday.

January 10, 2011

The Food and Drug Administration has approved a generic drug made by Watson Pharmaceuticals for cancer-related pain, Watson said Monday.

January 7, 2011

Nearly 500 retailers in Mississippi had to submit to Food and Drug Administration inspections concerning alleged tobacco sales to minors, the FDA said Friday.

January 7, 2011

The Food and Drug Administration has approved a generic contraceptive made by Sandoz, the company said.

January 7, 2011

International criminals are posing as Food and Drug Administration special agents and other law enforcement officers in order to extort money from consumers, the FDA warned Friday.

January 6, 2011

The Food and Drug Administration has accepted the approval application for a chemotherapy drug to treat lung cancer from AdventRx Pharmaceuticals, the drug maker said Thursday.

January 6, 2011

The Food and Drug Administration has expanded the approved usage of a drug made by Genentech, part of Swiss drug maker Roche.

January 6, 2011

The Food and Drug Administration granted priority review to an approval application for a hepatitis C drug made by Merck, the drug maker said Thursday.

January 5, 2011

PITTSBURGH — The Centers for Disease Control and Prevention and the Food and Drug Administration last year initiated programs that will breathe new life into sales of smoking-cessation products. The surgeon general issued a report titled “How Tobacco Smoke Causes Disease,” and the FDA will be mandating that tobacco manufacturers have smoking-is-bad-for-you messages on packaging. 


January 5, 2011

Certain tobacco products introduced to the market or changed after Feb. 15, 2007, are subject to enhanced scrutiny by the Food and Drug Administration, the agency said Wednesday.

January 5, 2011

The Food and Drug Administration has extended by six months the market exclusivity of a lung disease drug for use in children.

January 5, 2011

Food and Drug Administration principal deputy commissioner Joshua Sharfstein will leave the agency to become head of the Maryland Department of Health and Mental Hygiene, according to published reports.

January 5, 2011

Supplier News — The Food and Drug Administration has approved a generic drug for hypertension made by Mylan. Mylan announced the approval of nifedipine extended-release tablets in the 30-mg, 60-mg and 90-mg strengths. The drug is a generic version of Bayer’s Adalat CC. Nifedipine tablets had sales of around $82 million during the 12-month period ended June 2010, according to IMS Health.



 

January 5, 2011

Responding to what she termed an “unprecedented” shortage of prescription medicines for such serious conditions as cancer, Sen. Amy Klobuchar, D-Minn., is promising new legislation to deal with the problem.

January 4, 2011

The Food and Drug Administration has approved a topical testosterone replacement therapy made by Endo Pharmaceuticals, Endo said last week.

January 3, 2011

This past year saw a lower-than-usual number of new drugs approved by the Food and Drug Administration, due in part to delays at the agency, according to published reports.