January 25, 2011

Eisai will not seek regulatory approval for a drug to treat severe sepsis after getting lackluster results from a late-stage clinical trial, the drug maker said Tuesday.

January 25, 2011

Sanofi-Aventis and its U.S. consumer healthcare division Chattem on Tuesday afternoon announced the Food and Drug Administration has approved the Allegra (fexofenadine HCl) family of allergy medication products for over-the-counter use in adults and children 2 years of age and older.

January 25, 2011

Teva on Tuesday confirmed its receipt of an action letter from the Food and Drug Administration for its generic blood-thinning drug.

January 24, 2011

The Food and Drug Administration has accepted a regulatory filing from Optimer Pharmaceuticals for a drug to treat bacterial infections.

January 24, 2011

The Food and Drug Administration has approved a treatment for gastroesphageal reflux disease made by a subsidiary of Mylan, the generic drug maker said Monday.

January 24, 2011

The Food and Drug Administration has approved a new drug for treating major depressive disorder, the agency said Friday.

January 21, 2011

Generic drug maker Watson Pharmaceuticals expects sales of $4.2 billion for 2011, the company said Friday.

January 20, 2011

It seems that MannKind has experienced a setback with a drug designed to control hyperglycemia in Type 1 and Type 2 diabetes patients.

January 20, 2011

The Food and Drug Administration has given tentative approval to an antiretroviral treatment for children with HIV and AIDS under the President’s Emergency Plan for AIDS Relief program.

January 20, 2011

The Food and Drug Administration and Health Canada have granted priority review to a drug for treating hepatitis C.

January 19, 2011

Drug maker Genentech is hoping to keep a breast cancer treatment on the market as the Food and Drug Administration considers whether to revoke its approval for the disease, according to published reports.

January 19, 2011

A permanent injunction was granted to the federal government Tuesday against a contract manufacturer and distributor of prescription and over-the-counter products, as well as two of its executives.

January 19, 2011

In response to articles that appeared in several media outlets about its generic drug pipeline, drug maker Impax Labs is looking to set the record straight.

January 18, 2011

The Food and Drug Administration has approved a new treatment for head lice, the agency said Tuesday.

January 18, 2011

The Food and Drug Administration has approved a generic diabetes drug made by Mylan, the drug maker said Tuesday.

January 18, 2011

Transcept Pharmaceuticals has resubmitted its regulatory application for a drug to treat insomnia to the Food and Drug Administration, following a previous denial of approval by the agency, the drug maker said Tuesday.

January 17, 2011

A new drug application for Anglo-Swedish drug maker AstraZeneca's vandetanib has been extended.

January 17, 2011

A Food and Drug Administration advisory committee voted last week not to recommend approval of a drug from Eli Lilly.

January 17, 2011

After announcing its voluntary recall of certain products at a wholesaler level on Friday, Johnson & Johnson's McNeil Consumer Healthcare division provided an update on its internal assessment phase of its comprehensive action plan.

January 14, 2011

The Food and Drug Administration has approved a new formulation of a drug for treating acetaminophen poisoning.

January 14, 2011

The Food and Drug Administration and drug maker Sanofi-Aventis are warning healthcare professionals and patients about the possibility of severe liver injury in patients taking a Sanofi heart drug.

January 14, 2011

In consultation with the Food and Drug Administration, McNeil Consumer Healthcare on Friday voluntarily recalled certain lots of Tylenol 8 Hour, Tylenol Arthritis Pain and Tylenol upper respiratory products, as well as certain lots of Benadryl, Sudafed PE and Sinutab products at the wholesale level.

January 14, 2011

Pernix Therapeutics Holdings on Wednesday announced an exclusive co-promotion agreement with ParaPro for a medication to treat head lice.

January 13, 2011

The student chapter of the nation’s oldest national pharmacists’ organization has teamed up with the federal government to launch a new outreach effort for improving medication safety.