The generic drug industry’s main lobby in Washington is hoping to head off cuts to the Food and Drug Administration’s Office of Generic Drugs, which it said could have a “devastating impact” on those who rely on generics.
Generic drug maker Mylan is suing the Food and Drug Administration in an effort to prevent Gurgaon, India-based competitor Ranbaxy Labs from launching its generic version of Pfizer’s cholesterol medication Lipitor, according to published reports.
It's about time lawmakers start to understand the real threats posed by drug reimportation and unlicensed Internet pharmacy sites. About 20% of the current members of Congress are newly elected, and there is this recurring, cyclical fascination among politicians that we can fix everything with drug reimportation. But mandating electronic track and trace right now is a bad idea.
Commenting on a counterfeit pharmaceutical inter-agency working group report, the National Association of Chain Drug Stores stressed that it shares the goal of improving the public awareness of the risks posed from counterfeit drugs and unlawful online drug sellers, but expressed concern over the report's proposal to mandate a "track-and-trace" system in the United States, given the high cost it could pose for pharmacies.
A drug under investigation as a treatment for a rare genetic disorder that causes abnormally high triglyceride levels in the blood has received orphan-drug designation from the Food and Drug Administration.
The Food and Drug Administration on Tuesday outlined a new campaign attacking fraudulent weight-loss products marketed as dietary supplements, especially those companies that proffer a “magic pill” that almost immediately achieves weight loss.
McNeil last week finalized the terms of a consent decree of permanent injunction with the Food and Drug Administration for manufacturing facilities operated by the McNeil Consumer Healthcare Division in Las Piedras, Puerto Rico; Fort Washington, Pa.; and Lancaster, Pa.
Sugar and chalk. That’s what Pfizer researchers found in a pill that was supposed to be Cytotec but was, in fact, a crude knock-off seized from a counterfeit drug lab in Peru. The "60 Minutes" segment came as no surprise to Drug Store News, which has argued for many years that drug counterfeiting is the key reason lawmakers need to forget the recurring pipe dream they share that rogue Internet sites and drug reimportation is a legitimate solution to rising healthcare costs.
While failing to improve overall survival, an investigational treatment for non-small cell lung cancer made by Sanofi-Aventis and Regeneron Pharmaceuticals did keep the disease from worsening and, overall, caused patients to respond to treatment, according to results of a late-stage clinical trial.
Eli Lilly leader John Lechleiter has become something of an evangelist for medical innovation lately. On Wednesday, the Lilly chairman, president and CEO spoke to the U.S./Japan Business Council in Tokyo to call for changes and policies in the biopharmaceutical industry that encourage innovation, or “reinventing invention,” as he called it.
SUPPLIER NEWS — Impax Labs received regulatory approval from the Food and Drug Administration for its generic version of a bacterial infection treatment. The drug maker said the FDA approved its 150-mg doxycycline monohydrate capsules, a drug used to treat bacterial infections and a generic version of Adoxa, made by Nycomed subsidiary PharmaDerm. The 150-mg strength of Adoxa had sales of about $25 million during the 12 months ended in December 2010, according to Wolters Kluwer.