Content about Food and Drug Administration

December 18, 2012

The Food and Drug Administration has approved a new four-strain flu vaccine made by GlaxoSmithKline, the drug maker said.

December 18, 2012

More than two-thirds of generic drugs carry safety warning labels different from those of their branded equivalents, according to a new study.

December 18, 2012

Drug maker Merz Pharmaceuticals is suing Par Pharmaceutical over the latter's attempt to market a generic drug for cerebral palsy patients, according to published reports.

December 17, 2012

The Food and Drug Administration has approved a new biotech drug from GlaxoSmithKline for anthrax, the drug maker said.

December 17, 2012

The Food and Drug Administration has approved a new drug to treat a rare but serious endocrine disorder.

December 17, 2012

The consumer products division of British drug maker GlaxoSmithKline wants its voice heard at a Food and Drug Administration hearing scheduled for next year on a section in a 2009 law to regulate tobacco products that deals with smoking-cessation products, the company said Monday.

December 14, 2012

The Food and Drug Administration has approved a new leukemia drug made by Ariad Pharmaceuticals, the agency said.

December 14, 2012

A federal court has ruled in favor of AstraZeneca in a case regarding a cholesterol drug, the company said.

December 13, 2012

GlaxoSmithKline Consumer Healthcare and TV personality Samantha Harris have teamed up to announce the launch of "Let's Fight Holiday Fat" — a new, free online guide that provides weight maintenance support for Americans trying to squeeze in healthy eating and exercise this season.

December 12, 2012

The Food and Drug Administration has accepted a regulatory approval application from Takeda and Lundbeck for an experimental drug to treat depression, the companies said Wednesday.

December 12, 2012

A subsidiary of Johnson & Johnson is seeking regulatory approval for a new Type 2 diabetes drug.

December 12, 2012

A national group representing state boards of pharmacy has announced its support for efforts to strengthen regulations on compounding pharmacies.

December 11, 2012

The Food and Drug Administration is allowing a drug made by Eisai for treating gastroesophageal reflux disease to retain its market exclusivity for six months past the original expiration date, the company said.

December 11, 2012

The Supreme Court will review settlements between branded and generic drug companies that critics say delay patients' access to cheaper drug treatments, according to published reports.

December 10, 2012

The Food and Drug Administration has approved a new use for a cancer drug made by Johnson & Johnson, the agency said Monday.

December 10, 2012

Astellas Pharma US has announced the Food and Drug Administration's approval to review the new drug application for tacrolimus extended-release capsules.

December 10, 2012

Following last week's news that the influenza season has gotten off to an early start, Medline issued a release recommending the company's BioMask facemask as adequate protection against contracting the flu.

December 10, 2012

A Congressional committee is looking into allegations that a compounding pharmacy industry association may have taught pharmacists how to sidestep requests for samples from the Food and Drug Administration, according to published reports.

December 7, 2012

Authorities in Massachusetts are looking to tighten regulations on compounding pharmacies as the state health department announced some changes to the makeup of the Massachusetts Board of Pharmacy and sent cease-and-desist notices to three compounding pharmacies for alleged violations.

Retail pharmacies looking to get into sterile compounding and exercise greater control over that supply chain — as Walgreens did last month when it bought an independent specialty compounding pharmacy in Indiana — should take note because it seems there will be increased scrutiny on the practice following a nationwide outbreak of meningitis linked to alleged unsanitary conditions at the Framingham, Mass.-based New England Compounding Center.

December 7, 2012

The Food and Drug Administration has approved a generic hypertension drug made by Mylan, the company said.

December 6, 2012

The Food and Drug Administration has given special designation to a treatment made by Biodel for patients with congenital hyperinsulinism, a rare disorder that affects children.

December 6, 2012

Johnson & Johnson is seeking approval from the Food and Drug Administration for a drug to treat active psoriatic arthritis, the company said Thursday.

December 4, 2012

The Food and Drug Administration will review an acid-reflux drug made by Eisai for use in children, the drug maker said.

November 30, 2012

The Food and Drug Administration has approved a new drug made by Exelixis for treating thyroid cancer, the agency said.

© 2013 Drug Store News. All Rights Reserved.