January 24, 2012

The Food and Drug Administration has approved a new manufacturing plant that will be operated by drug maker Genzyme.

January 23, 2012

A panel of experts at the Food and Drug Administration has declined to recommend approval for a topical drug for preventing premature birth in pregnant women, the drug's manufacturers said.

January 23, 2012

Perrigo is seeking approval from the Food and Drug Administration for a drug used to treat allergies in adolescents and adults, the company said Monday.

January 23, 2012

The Food and Drug Administration is streamlining the enrollment process for risk evaluation and mitigation strategies for a class of painkillers, the agency said.

January 20, 2012

One issue that is unlikely to see resolution this year is the growing problem of drug shortages. As of October 2011, the Food and Drug Administration and the American Society of Health Systems Pharmacists found shortages of 168 drugs.

January 20, 2012

One analysis report after another seems to confirm that the generic drug market is in for a huge shift as the number of blockbuster drugs losing patent protection is set to dwindle over the next several years. A recent report by Frost & Sullivan seems to confirm that sentiment.

January 20, 2012

It has become a perennial issue, and one that is likely to crop up at least once this year: patent settlements.


January 20, 2012

For all the talk about generic drugs and their potential to save piles of money for the country’s healthcare system, it’s going to be a while before many of them actually reach consumers because of the Food and Drug Administration’s huge backlog of generic drug regulatory approval applications.


January 20, 2012

In the Feb. 7, 2011, issue, Drug Store News named three major issues that would define 2011 for the world of generic drugs. Those issues were drug safety, generic user fees and patent settlements.

January 19, 2012

The Food and Drug Administration has declined to approve a drug for Type 2 diabetes made by Bristol-Myers Squibb and AstraZeneca, saying it needs additional clinical data, the companies said Thursday.

January 19, 2012

The Food and Drug Administration has approved a lower-dose formulation of a drug made by Gilead Sciences for treating HIV in children, the company said.

January 19, 2012

Drug maker Sandoz has started two late-stage clinical trials of biosimilar drugs for treating cancer patients undergoing chemotherapy, the company said Thursday, saying the studies were meant to support the drugs' eventual marketing in the United States.

January 18, 2012

The Food and Drug Administration has provided guidance to Provectus Pharmaceuticals as the drug maker prepares to apply with the agency for approval to start a late-stage clinical trial of a drug for skin cancer, Provectus said Wednesday.

January 16, 2012

The Food and Drug Administration's latest message to consumers and healthcare professionals seems like a no-brainer: "Insulin pens are not for sharing."

January 16, 2012

The Food and Drug Administration has finished and sent to Congress its recommendations for a proposed Generic Drug User Fee Act, drawing praise from the generic drug industry.

January 13, 2012

MagnaCare, a health plan management company, on Thursday announced its partnership with Telcare on that company's new wireless-enabled blood glucose meter.

January 12, 2012

Roche on Wednesday announced it has received clearance from the Food and Drug Administration for its Accu-Chek Nano SmartView blood-glucose monitoring system.

January 10, 2012

Nicotine replacement therapies designed to help people stop smoking, specifically nicotine patches and nicotine gum, do not appear to be effective in helping smokers quit long-term, even when combined with smoking-cessation counseling, according to a new survey by researchers at Harvard School of Public Health and the University of Massachusetts Boston posted in an advance online edition of Tobacco Control Monday.

January 9, 2012

Endo Pharmaceuticals announced a short-term supply constraint of analgesic products, including Opana ER, due to the temporary shutdown of a manufacturing facility operated by Novartis Consumer Health.

January 9, 2012

Generic drug maker Mylan is challenging the patent on a drug used to treat diabetes, the company said Monday.

January 6, 2012

The Food and Drug Administration has granted fast-track designation to a drug currently under development by Achillion Pharmaceuticals for hepatitis C, the company said.

January 5, 2012

Medtronic has launched a blood-glucose monitor that allows remote monitoring of blood-glucose levels, the company said.

January 4, 2012

The Food and Drug Administration has approved a generic version of a drug for attention deficit hyperactivity disorder made by Actavis, the drug maker said Wednesday.

January 4, 2012

Perrigo last week announced that it has received final Food and Drug Administration approval for its generic prescription allergy remedy desloratadine 5 mg, the generic equivalent to Schering-Plough's Clarinex.