September 22, 2011

Drug maker Orexigen Therapeutics said it had identified a "clear and feasible path" for the approval of its drug for treating obesity by working with the Food and Drug Administration.

September 22, 2011

Epinephrine inhalers will not be made or sold after Dec. 31, and patients using them should get new prescriptions to replace them, the Food and Drug Administration said Thursday.

September 21, 2011

Researchers at the University of California Los Angeles said they have found a possible link between two new drugs for Type 2 diabetes and cancers of the pancreas and thyroid, according to a new study published in the journal Gastroenterology.

September 20, 2011

Mylan subsidiary Matrix Labs has received tentative approval from the Food and Drug Administration for its new drug application of a co-packaged antiretroviral treatment under the President's Emergency Plan for AIDS Relief.

September 20, 2011

The Food and Drug Administration has approved a generic version of a deep vein thrombosis treatment.

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.