December 19, 2012

A single lot of a congestion-relief product has been recalled due to bacterial contamination found in a sample, the Food and Drug Administration said Wednesday.

December 18, 2012

The Food and Drug Administration has approved two generic versions of a drug to treat HIV, according to agency records.

December 18, 2012

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

December 17, 2012

The consumer products division of British drug maker GlaxoSmithKline wants its voice heard at a Food and Drug Administration hearing scheduled for next year on a section in a 2009 law to regulate tobacco products that deals with smoking-cessation products, the company said Monday.

December 14, 2012

The Food and Drug Administration has approved a new leukemia drug made by Ariad Pharmaceuticals, the agency said.

December 13, 2012

GlaxoSmithKline Consumer Healthcare and TV personality Samantha Harris have teamed up to announce the launch of "Let's Fight Holiday Fat" — a new, free online guide that provides weight maintenance support for Americans trying to squeeze in healthy eating and exercise this season.

December 12, 2012

The Food and Drug Administration has accepted a regulatory approval application from Takeda and Lundbeck for an experimental drug to treat depression, the companies said Wednesday.

December 12, 2012

A subsidiary of Johnson & Johnson is seeking regulatory approval for a new Type 2 diabetes drug.

December 11, 2012

The Food and Drug Administration is allowing a drug made by Eisai for treating gastroesophageal reflux disease to retain its market exclusivity for six months past the original expiration date, the company said.

December 11, 2012

The Supreme Court will review settlements between branded and generic drug companies that critics say delay patients' access to cheaper drug treatments, according to published reports.

December 10, 2012

The Food and Drug Administration has approved a new use for a cancer drug made by Johnson & Johnson, the agency said Monday.

December 10, 2012

Astellas Pharma US has announced the Food and Drug Administration's approval to review the new drug application for tacrolimus extended-release capsules.

December 7, 2012

The Food and Drug Administration has approved a generic hypertension drug made by Mylan, the company said.

December 4, 2012

The Food and Drug Administration will review an acid-reflux drug made by Eisai for use in children, the drug maker said.

November 30, 2012

The Food and Drug Administration has approved a new drug made by Exelixis for treating thyroid cancer, the agency said.

November 29, 2012

The Food and Drug Administration approved a new generic drug made by Mylan for urinary disorders, the company said Thursday.

November 29, 2012

A Food and Drug Administration panel has voted to recommend approval for a Johnson & Johnson drug to treat tuberculosis while the agency has recommended accelerated approval for the drug, the company said.

November 29, 2012

Patent settlements between generic and branded drug companies seem like one of the most controversial and long-standing issues in the pharmaceutical world, with strong opinions on both sides.


November 29, 2012

Generic Pharmaceutical Association president and CEO Ralph Neas called it “the most important pharmaceutical legislation since the 1984 Hatch-Waxman Act.” John Castellani, president and CEO of the Pharmaceutical Research and Manufacturers of America, said the law served “the best interests of America’s patients.”


November 28, 2012

Some legislators are concerned with the way energy drinks can affect young consumers.

November 28, 2012

The Food and Drug Administration has approved a drug from Perrigo and Cobrek Pharmaceuticals for treating scalp conditions.

November 27, 2012

Indian generic drug maker Wockhardt received three new drug approvals from the Food and Drug Administration, agency records show.

November 19, 2012

The Food and Drug Administration has approved a drug for a condition that can complicate treatment for hepatitis C.

November 19, 2012

The year 2012 is coming to an end, and it's been a big year for generic drugs. It's the year that the most lucrative drug of all time became commoditized. It's the year that Watson bought Actavis for $5.6 billion. And it's the year the FDA released draft guidance for biosimilars regulations. All of these events speak to some of the most important trends in the world of generics — trends that are often interrelated.