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.

March 4, 2011

SUPPLIER NEWS — Impax Labs received regulatory approval from the Food and Drug Administration for its generic version of a bacterial infection treatment. The drug maker said the FDA approved its 150-mg doxycycline monohydrate capsules, a drug used to treat bacterial infections and a generic version of Adoxa, made by Nycomed subsidiary PharmaDerm. The 150-mg strength of Adoxa had sales of about $25 million during the 12 months ended in December 2010, according to Wolters Kluwer.

March 3, 2011

The Food and Drug Administration has approved a generic drug for pain and inflammatory diseases made by Amneal Pharmaceuticals, Amneal said Thursday.

March 3, 2011

The Food and Drug Administration declined to approve a Merck KGaA drug designed to treat relapsing-remitting multiple sclerosis.

March 2, 2011

A group of drug makers have sued Mylan over its attempt to gain Food and Drug Administration approval for a generic menopause drug, Mylan said Tuesday.

March 2, 2011

The Food and Drug Administration has taken action against makers of prescription drugs for cough-cold and allergies that don’t have regulatory approval, the agency said Wednesday.

March 2, 2011

Following the warning letter it received last April, Perrigo announced that the Food and Drug Administration has arrived at the company's Allegan, Mich.-based facility for re-inspection.

March 2, 2011

The Food and Drug Administration is warning that long-term use of a class of drugs for gastroesophageal reflux disease may decrease levels of magnesium in the body and increase the risk of such side effects as seizures and heart rhythm problems, according to published reports.

March 1, 2011

The Food and Drug Administration has approved a treatment for chronic obstructive pulmonary disease made by Forest Labs, the agency said Tuesday.

February 28, 2011

The Food and Drug Administration has approved a GlaxoSmithKline drug for a rare blood disorder, GSK said Friday.

February 28, 2011

The Food and Drug Administration has approved a new use for a Shire drug to treat attention deficit hyperactivity disorder, Shire said Monday.

February 28, 2011

The Food and Drug Administration has approved a treatment for shingles made by a subsidiary of generic drug maker Mylan.

February 28, 2011

British drug maker Shire again is trying to win approval for a hereditary angioedema drug that the Food and Drug Administration had previously declined to approve.

February 28, 2011

The Food and Drug Administration has approved a new treatment for hypertension, also known as high blood pressure, the agency said Friday.

February 25, 2011

More than 400 drugs are in late-stage clinical development or awaiting Food and Drug Administration approval as treatments for rare diseases, according to a report by the drug industry lobby.

February 25, 2011

The Food and Drug Administration has declined to approve a biologic treatment for a rare genetic disorder by Israeli drug maker Protalix Biotherapeutics, Protalix said Friday.