April 9, 2012

The Food and Drug Administration's New Dietary Ingredient Draft Guidance should not give the agency pre-market approval over new dietary supplement products, the Council for Responsible Nutrition claimed Monday in a commentary published in Regulatory Toxicology and Pharmacology, the official journal of the International Society of Regulatory Toxicology and Pharmacology.

April 9, 2012

The Food and Drug Administration has approved a change to the label of a Novo Nordisk drug stating that it offers superior blood-sugar control to a competing drug made by Merck, based on results of two clinical studies, Novo Nordisk said Monday.

April 6, 2012

A panel of Food and Drug Administration experts has recommended approval for a drug made by Astellas Pharma for overactive bladder.

April 5, 2012

OraSure Technologies on Wednesday announced that the Food and Drug Administration's Blood Products Advisory Committee will consider making its OraQuick Rapid HIV-1/2 test available over the counter on May 15.

April 5, 2012

Teva is the first company to file for a generic version of a drug to treat sleep disorders, the Food and Drug Administration has determined.

April 4, 2012

The Food and Drug Administration has approved a patch for treating restless legs syndrome and Parkinson's disease.

April 4, 2012

A court has ruled that patents covering a drug used for overactive bladder are invalid, a company looking to launch a generic version of the drug said.

April 4, 2012

People ages 65 years and older reduced their volume of prescriptions, while those ages 19 to 25 years increased their use of prescription drugs as the healthcare-reform law allowed them to remain on their parents' insurance, according to a new report by IMS Health.

April 3, 2012

Drug maker Amylin Pharmaceuticals has filed for regulatory approval of a drug to treat diabetes and elevated triglycerides in the bloodstream in children and adults with a rare disorder.

April 3, 2012

The Food and Drug Administration on Friday released draft guidance that ultimately will provide the public with previously unknown information about the chemicals in tobacco products and help prevent misleading marketing about the risks associated with tobacco products, the agency said.

April 3, 2012

Watson is challenging the patent protection on two eye drugs made by Allergan, the generic drug maker said Tuesday.

April 2, 2012

A diabetes treatment made by Novo Nordisk is safe for pregnant women, according to a recent decision by the Food and Drug Administration.

March 29, 2012

Regulators will take a few months longer to review the approval application for a new drug for treating chronic obstructive pulmonary disease, the drug's developers said Thursday.

March 28, 2012

The Food and Drug Administration has approved a new treatment for anemia in patients with chronic kidney disease.

March 28, 2012

Three companies have launched generic versions of a psychiatric drug made by AstraZeneca following a court decision turning down the Anglo-Swedish drug maker's request for an injunction against the Food and Drug Administration's approval of the generics.

March 27, 2012

The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating HIV in children.

March 26, 2012

A federal court has dismissed a case that drug maker AstraZeneca filed against regulators regarding a drug used to treat psychotic and bipolar disorders, the company said Monday.

March 26, 2012

The Food and Drug Administration has approved a drug made by Teva for treating allergies, the company said Monday.

March 26, 2012

A drug under development by Forest Labs and Pierre Fabre has been shown to reduce symptoms of major depressive disorder, the companies said.

March 26, 2012

The recent Food and Drug Administration public meeting on driving future switch potential by way of the pharmacist and/or health technology sparked some discussion on what’s next.


March 22, 2012

The Food and Drug Administration's director of the Center for Drug Evaluation and Research, Janet Woodcock, on Thursday identified three tools the agency wanted to use in potentially increasing access to appropriate medicines in her opening remarks at the FDA Rx-to-OTC Switch Hearing.

March 22, 2012

GlaxoSmithKline on Thursday morning presented exactly how technology might improve appropriate patient self-selection before a panel convened by the Food and Drug Administration to explore expanding the prescripton-to-over-the-counter switch paradigm by incorporating technology and/or pharmacy participation in the application process.

March 21, 2012

A Food and Drug Administration expert panel delivered a favorable vote on a cancer drug made by GlaxoSmithKline.

March 21, 2012

The Food and Drug Administration has approved Watson's generic version of a drug used to prevent and treat osteoporosis in post-menopausal women, the company said.