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

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

With the patent cliff and subsequent innovation drought moving closer, generic drug makers are looking to move up the value chain and pursue new sources of revenue, and of all the piles of pay dirt out there, biosimilars represent one of the closest things to an El Dorado, though regulations won’t take their final form for a while.


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 20, 2012

If the patent cliff were a sports team, Pfizer’s cholesterol-
lowering drug Lipitor (atorvastatin) would be its mascot.

January 19, 2012

The National Community Pharmacists Association is calling for the Centers for Medicare and Medicaid Services to allow senior patients to enroll in a new Medicare Part D prescription drug plan via a special enrollment period, particularly if patients believe that "material misrepresentations" led them to sign up for a "preferred network" plan with inadequate pharmacy access.

January 19, 2012

Generic drug maker Watson Pharmaceuticals has launched its version of a contraceptive made by Bayer HealthCare Pharmaceuticals, Watson said.

January 18, 2012

A wide range of factors and "moving parts" will likely make 2012 a challenging year for pharmacy retailers as the economy, generic drugs and the dispute between Walgreens and Express Scripts figure prominently, analysts say.

January 18, 2012

Patent expirations of key blockbuster drugs and efforts by payers to contain costs are likely to bring strong growth to the global generic drug market in the next few years as market-earned revenues grow by more than $100 billion, according to an analysis by research firm Frost & Sullivan.

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 17, 2012

A committee formed by Taro Pharmaceutical Industries in December is continuing to evaluate an acquisition offer by India-based Sun Pharmaceutical Industries, Taro said.

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 12, 2012

Prasco Labs will act as the distributor for an authorized generic version of a Shire anticonvulsant drug, the company said Thursday.

January 9, 2012

CVS Caremark has entered into a definitive agreement to purchase the stand-alone Medicare Part D prescription drug plan business from Health Net for approximately $160 million in cash.

January 9, 2012

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

January 3, 2012

Mylan has launched a generic drug for treating high blood pressure, the company said.

January 3, 2012

While physicians and pharmacists alike generally view electronic prescribing with favor, several barriers stand in the way of their realizing its full benefit, according to a November government study.


December 21, 2011

Ranbaxy Labs said Wednesday that it had resolved long-standing issues concerning two of its manufacturing plants in India with the U.S. government.

December 20, 2011

The Council for Responsible Nutrition and VIRGO on Tuesday announced details for an industrywide webinar to examine key elements of good manufacturing practices for dietary supplements and offer advice as to what the industry can do to improve its record of inspections.

December 19, 2011

What new prescription and OTC drugs are top of mind among retail pharmacists? How often do pharmacists REALLY recommend private label?