Regulatory Affairs Syndicator

ROCKVILLE, Md., Feb. 23 /PRNewswire/ — Otsuka Maryland Research Institute, Inc. (OMRI) announced that the Food and Drug Administration has granted Fast Track designation to their product tolvaptan for the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD).

The U.S. Food and Drug Administration clarified its definition of “whole grains” last week, several months after recommending that Americans incorporate more whole grains in their diets.

The U.S. Food and Drug Administration has approved for review a new drug application that involves Replidyne Inc., a Louisville biophamaceutical company.

Guidant Corp. said Thursday the U.S. Food and Drug Administration cited the company for one problem at its cardiac rhythm management facilities in Arden Hills.

INDIANAPOLIS — Food and Drug Administration inspectors say medical device maker Guidant Corporation waited more than a year to tell federal regulators that it had repaired software in a line of defibrillators.

The U.S. Food and Drug Administration clarified its definition of “whole grains” last week, several months after recommending that Americans incorporate more whole grains in their diets.

Mylan Laboratories Inc. got tentative approval from the U.S. Food and Drug Administration for Carvedilol, a generic version of GlaxoSmithKine’s blood pressure drug Coreg.

GlaxoSmithKline faced more potentially bad news Thursday when Pittsburgh pharmaceutical company Mylan Laboratories announced that the U.S. Food and Drug Administration has granted “tentative approval” for Mylan’s generic version of beta-blocker Coreg.

PITTSBURGH, Feb. 23 /PRNewswire-FirstCall/ — Mylan Laboratories Inc. today announced that the U.S. Food and Drug Administration has granted tentative approval for Mylan Pharmaceuticals Inc.’s Abbreviated New Drug Application for Carvedilol Tablets 3.125 mg, 6.25 mg, 12.5 mg and 25 mg.

WASHINGTON (AP) — Next year’s flu vaccine will contain protection against two newer strains of influenza, a Food and Drug Administration committee decided Friday.

The U.S. Food and Drug Administration said yesterday that drugmakers had flooded it with commercials for review under their new advertising-ethics code.

Heart device maker Guidant Corp. said Thursday that the Food and Drug Administration found a deficiency in how the company is identifying quality problems at its St. Paul, Minn. cardiac rhythm management plant.

Heart device maker Guidant Corp. said Thursday that the Food and Drug Administration found a deficiency in how the company is identifying quality problems at its St. Paul, Minn. cardiac rhythm management plant.

Despite objections from dermatologists, the U.S. Food and Drug Administration will stick to March 1 as the start date for iPledge, a program designed to prevent birth defects caused by an acne drug.

DUBLIN, Ireland—-Feb. 23, 2006–Research and Markets has announced the addition of Global Market Review of Trans Fats - With Future Outlook to their offering.