Content about Food and Drug Administration

March 17, 2011

Anglo-Swedish drug maker AstraZeneca has enrolled the first patient in a late-stage clinical trial for a drug to treat constipation related to use of opioid painkillers, the company said.

March 17, 2011

Commenting on a counterfeit pharmaceutical inter-agency working group report, the National Association of Chain Drug Stores stressed that it shares the goal of improving the public awareness of the risks posed from counterfeit drugs and unlawful online drug sellers, but expressed concern over the report's proposal to mandate a "track-and-trace" system in the United States, given the high cost it could pose for pharmacies.

March 17, 2011

The Natural Products Association on Wednesday outlined five key industry issues for the U.S. Department of Commerce and the Office of the United States Trade Representative for the U.S.-China Joint Commission on Commerce and Trade.

March 16, 2011

The Food and Drug Administration on Wednesday announced that the only over-the-counter asthma inhaler sold in the United States no longer will be available as of Dec. 31 as part of an international agreement to stop the use of substances that damage the environment.

March 15, 2011

A drug under investigation as a treatment for a rare genetic disorder that causes abnormally high triglyceride levels in the blood has received orphan-drug designation from the Food and Drug Administration.

March 15, 2011

A generic painkiller made by Watson Pharmaceuticals does not infringe on the patent covering the branded version, a U.S. District Court has ruled.

March 15, 2011

The Food and Drug Administration on Tuesday outlined a new campaign attacking fraudulent weight-loss products marketed as dietary supplements, especially those companies that proffer a “magic pill” that almost immediately achieves weight loss.

March 15, 2011

Five senators have issued a letter to Food and Drug Administration commissioner Margaret Hamburg to expand Americans' access to affordable medications by avoiding the delay of generic drug approvals.

March 15, 2011

Patients that opt to fill their prescriptions through a $4 generic program could help garner societal savings of nearly $6 billion, a new study found.

March 14, 2011

McNeil last week finalized the terms of a consent decree of permanent injunction with the Food and Drug Administration for manufacturing facilities operated by the McNeil Consumer Healthcare Division in Las Piedras, Puerto Rico; Fort Washington, Pa.; and Lancaster, Pa.

March 11, 2011

The Food and Drug Administration has approved biotech company Dendreon’s expansion of manufacturing capacity for an immunotherapy treatment for prostate cancer, Dendreon said Thursday.

March 10, 2011

The Food and Drug Administration has approved a treatment for lupus made by GlaxoSmithKline and Human Genome Sciences, the agency said Wednesday.

March 10, 2011

The Food and Drug Administration is putting its weight behind a campaign by the National Consumers League to combat poor medication adherence.

March 10, 2011

Hospira has received approval from the Food and Drug Administration for a generic cancer treatment.

March 10, 2011

A subsidiary of Mylan has won approval to sell a generic drug for HIV and AIDS in developing countries under the President’s Emergency Plan for AIDS Relief.

March 9, 2011

FRS Healthy Energy on Tuesday announced the launch of new Healthy Protein and Healthy Energy formulas to be shipped in April.

March 9, 2011

The Food and Drug Administration has accepted an approval application from Merck for a drug to treat eye diseases, Merck said Wednesday.

March 9, 2011

The Food and Drug Administration has accepted a regulatory approval application from Tris Pharma for a drug to treat allergies in children ages 2 years and older, Tris said Wednesday.

March 8, 2011

The Food and Drug Administration has accepted a regulatory approval application for a Type 2 diabetes drug from Bristol-Myers Squibb and AstraZeneca, the two drug makers said Tuesday.

March 8, 2011

The Food and Drug Administration declined to approve a drug made by Salix Pharmaceuticals for irritable bowel syndrome, Salix said Tuesday.

March 4, 2011

The Food and Drug Administration has approved a drug made by Eisai to treat a rare form of epilepsy, the drug maker said Friday.

March 4, 2011

Gilead on Friday announced that the Food and Drug Administration has removed a boxed warning about a possible liver injury risk caused by the drug maker's hypertension treatment.

March 4, 2011

Pregnant mothers taking a common drug for treating epilepsy may be putting their babies at risk, according to a new report from the Food and Drug Administration.

March 4, 2011

A subsidiary of Endo Pharmaceuticals has won approval from the Food and Drug Administration for an oral contraceptive.

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