January 28, 2011

Though Schering-Plough’s — now Merck’s — Claritin and Johnson & Johnson’s Zyrtec product lines have dominated the over-the-counter antihistamine market, the big share of the prescription antihistamine market held by Sanofi-Aventis’ Allegra (fexofenadine hydrochloride) could give it a battering ram to bust in as well, thanks to the big break Sanofi got in the form of a Food and Drug Administration approval of an OTC switch for the drug.

January 28, 2011

The Food and Drug Administration has approved a generic hypertension treatment made by Mylan.

January 27, 2011

The Food and Drug Administration has accepted a regulatory approval application for a pain drug that it previously had declined to approve.

January 27, 2011

The safety of silicone breast implants has long been a subject of controversy, but a review by the Food and Drug Administration indicated another possible health risk.

January 27, 2011

The Food and Drug Administration declined to approve a regulatory approval application from British drug maker GlaxoSmithKline concerning a cancer drug, GSK said Wednesday.

January 26, 2011

Watson Pharmaceuticals is seeking regulatory approval for a generic drug for high cholesterol.

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.