September 19, 2011

The Food and Drug Administration has approved two new uses for a drug made by Amgen, the drug maker said Monday.

September 15, 2011

The Food and Drug Administration has approved a generic drug for epilepsy made by Lupin Pharmaceuticals, the drug maker said.

September 14, 2011

A recent federal court ruling could have big implications for compounding pharmacies.

September 13, 2011

Impax Labs has hit a roadblock in its attempt to market a generic version of a symptomatic benign prostatic hyperplasia drug.

September 12, 2011

The Food and Drug Administration is reorganizing its division for regulating cancer drugs, the agency said Monday.

September 12, 2011


As the clock winds down on the patent exclusivity of the industry’s biggest blockbuster drug in November, speculation continues to grow that Pfizer will look to flip the switch on an OTC version of Lipitor (atorvastatin) before generic competition whittles away at the $7 billion behemoth. 


September 12, 2011

The issue of patent settlements, their effect on drug prices and availability, and by extension their legality has been around for a long time and will likely remain an issue for years to come. But according to a report released in May by the Federal Trade Commission, the settlements have been on the rise, increasing from 16 in 2009 to 31 in 2010.


September 12, 2011

Genentech has applied for Food and Drug Administration approval of a drug for treating skin cancer, the drug maker said Monday.

September 12, 2011

While settlements constitute the most prominent patent-related issue for generic drugs, two others have cropped up this year as well.


September 12, 2011

At press time, Hurricane Irene was slowly barreling toward the East Coast and threatening the area with a deluge that prompted cities to shut down and had store shelves wiped clean.


September 9, 2011

The Food and Drug Administration has approved a generic drug made by Mylan for treating allergies.

September 7, 2011

The Food and Drug Administration has accepted a regulatory approval application for a drug made by Vivus for treating erectile dysfunction.

September 6, 2011

Francesco International on Tuesday released a Rx-to-OTC projection report covering potential switches through 2016.

September 1, 2011

The Food and Drug Administration has approved a generic skeletal muscle relaxant made by Sagent Pharmaceuticals, Sagent said.

September 1, 2011

Branded drugs sold under their generic names at a reduced price can reduce retail and wholesale drug prices, according to a new report by the Federal Trade Commission.

September 1, 2011

The Food and Drug Administration has approved a new use for a follow-on biologic made by Sandoz.

August 31, 2011

Lupin has received final approval from the Food and Drug Administration for a generic version of a drug designed to treat moderate to moderately severe chronic pain in adults who require around-the-clock treatment for an extended period of time.

August 30, 2011

The Food and Drug Administration has accepted a regulatory approval application from Progenics Pharmaceuticals and Salix Pharmaceuticals seeking an additional approval for a pain drug.

August 30, 2011

The Food and Drug Administration has approved a treatment for dermatitis made by Perrigo under a collaboration with Chicago-based Cobrek Pharmaceutical.

August 30, 2011

A federal court has acted in favor of Teva Pharmaceutical Industries in the drug maker's patent infringement case against several generic drug companies seeking to market versions of its multiple sclerosis drug.

August 30, 2011

Mylan will be banned temporarily from launching a generic drug for acne pending a federal court's decision whether or not to bar it, according to published reports.

August 29, 2011

The Food and Drug Administration has approved a new cancer drug made by Pfizer, the drug maker said.

August 26, 2011

The Food and Drug Administration has approved a drug made by Shire for a rare autoimmune condition, the agency said.

August 26, 2011

The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating chronic pain, a J&J subsidiary said Friday.