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.

December 21, 2010

An Anglo-Swedish drug maker said it is discontinuing further development of a drug that is designed to prevent a respiratory virus that infects the lungs and breathing passages.

December 20, 2010

Drug maker Amylin Pharmaceuticals has submitted the first of a series of sections of a regulatory approval application for a biotech drug to treat patients with a rare lipid disorder.

December 20, 2010

Drugs for bacterial infections and cancer, and one that could help shape regulations for biosimilars, are featured in the Food and Drug Administration’s annual "Generic Drug Roundup."

December 20, 2010

Drug makers King Pharmaceuticals and Acura Pharmaceuticals have submitted a regulatory approval application to the Food and Drug Administration for an opioid pain reliever.

December 17, 2010

The Food and Drug Administration has approved a new oral contraceptive developed by Bayer.

December 17, 2010

The Food and Drug Administration has turned down AstraZeneca’s regulatory approval application for a drug to treat heart disease, the drug maker said.

December 16, 2010

Just a few months after a Food and Drug Administration advisory committee recommended limiting the use of a Genentech drug designed to treat breast cancer, the regulatory agency is looking to revoke the approval altogether.

December 15, 2010

A prescription cough suppressant should be kept in childproof containers because of its candy-like appearance, the Food and Drug Administration warned Tuesday.

December 15, 2010

The dietary supplement industry’s leading trade associations on Wednesday joined forces with the Food and Drug Administration to support heightened efforts to address public health problems posed by products that are illegally marketed as dietary supplements but contain the same active ingredients as FDA-approved drugs or other ingredients that do not qualify as dietary ingredients.

December 15, 2010

A new Consumer Reports poll released Monday found that only one-fifth of U.S. adults were aware of having purchased food, medication or a product (other than a car) that was recalled in the past three years.