May 17, 2011

Perrigo on Monday announced that it has received final approval from the Food and Drug Administration for its abbreviated new drug application for over-the-counter ranitidine 150 (regular and cool mint), a generic version of Zantac 150.

May 10, 2011

The branded-drug division of Impax Labs plans to conduct early-stage clinical studies of an investigational drug for restless leg syndrome, the company said Tuesday.

April 21, 2011

GlaxoSmithKline and Valeant last week responded to the Food and Drug Administration's complete response letter for the companies' investigational anti-epileptic drug.

April 12, 2011

Perrigo on Tuesday announced that the Detroit office of the Food and Drug Administration has concluded its re-inspection of Perrigo's Allegan facility.

April 8, 2011

Watson announced that its subsidiary is seeking approval to market a generic version of a bacterial conjunctivitis treatment.

March 24, 2011

The Food and Drug Administration has extended its regulatory review period for Novartis' new drug application for its once-daily, long-term maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, as well as chronic bronchitis and/or emphysema, the drug maker said.

March 22, 2011

Hi-Tech Pharmacal was granted final approval from the Food and Drug Administration for its treatment of duodenal ulcers.

February 18, 2011

A generic drug maker received regulatory approval from the Food and Drug Administration for its generic version of a bacterial infection treatment.

January 31, 2011

Transcept announced Monday that the Food and Drug Administration has classified the drug maker's insomnia treatment as a complete class-2 response, and assigned the drug a Prescription Drug User Fee Act action date for this summer.

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 17, 2011

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

January 6, 2011

The Food and Drug Administration has accepted the approval application for a chemotherapy drug to treat lung cancer from AdventRx Pharmaceuticals, the drug maker said Thursday.

November 30, 2010

A generic version of a drug indicated to treat attention deficit hyperactivity disorder has hit a roadblock.

November 14, 2010

A backlog of more than 2,000 drug entities and devices is awaiting approval. That’s the...

November 14, 2010

K-V Pharmaceutical has created a new marketing subsidiary for generic drugs, the company said. K-V...

October 17, 2010

The Food and Drug Administration granted approval for Teva's abbreviated new drug application to market...

September 27, 2010

The Food and Drug Administration on Tuesday issued warning letters to three companies that manufacture...

September 26, 2010

More than a dozen top Food and Drug Administration officials will meet with generic drug...

September 26, 2010

Greenstone announced the launch of an authorized generic version of the Alzheimer’s disease drug Aricept...

August 31, 2010

A specialty biopharmaceutical company focused on the development and commercialization of innovative treatments for diabetes...

August 30, 2010

The Food and Drug Administration has pushed back its review date for a drug made...

August 30, 2010

A generic drug maker has filed an abbreviated new drug application for its version of...

July 21, 2010

While there is a need to modernize the regulatory structure of the cosmetics industry, the...

July 18, 2010

Eisai's new drug application for a drug designed as an adjunctive treatment of seizures associated...