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.

January 3, 2011

The Food and Drug Administration last week prompted the recall of two more products sold as supplements but adulterated with prescription medicines.

January 3, 2011

The Food and Drug Administration declined to approve a treatment for diabetic eye disease made by Alimera Sciences, the drug maker said Dec. 23.

January 3, 2011

The Food and Drug Administration approved three drugs made by Glenmark Generics last month and gave tentative approval to a fourth, the Indian generic drug maker said.

January 3, 2011

The Food and Drug Administration has approved an update to the label of a Johnson & Johnson drug for HIV, the company said Monday.

December 29, 2010

Recent news that the FDA has rejected Teva's application for a new lower-dose version of multiple sclerosis drug Copaxone likely will hold off the emergence of a generic version of the drug.

December 23, 2010

Merck on Wednesday announced that the Food and Drug Administration has approved Gardasil [human papillomavirus quadrivalent (types 6, 11, 16 and 18) vaccine, recombinant] for the prevention of anal cancer in males and females 9 to 26 years of age.

December 23, 2010

The Food and Drug Administration on Wednesday approved Novartis Pharmaceuticals’ Amturnide (aliskiren, amlodipine and hydrochlorothiazide) tablets for the treatment of high blood pressure, according to the pharma company.

December 23, 2010

The Food and Drug Administration has approved the first and only low-dose oral contraceptive to combine 0.8-mg norethindrone and 0.025-mg ethinyl estradiol in a chewable form, with four 75-mg ferrous fumarate (iron) placebo tablets, Watson Pharmaceuticals has announced.

December 22, 2010

The House of Representatives on Wednesday passed the Food Safety Modernization Act by a vote of 215-144 to wide industry aplomb.