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

Drug maker Bristol-Myers Squibb has donated $6.9 million to a nonprofit group that helps people pay for medical treatments, the company said.

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 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

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

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

Jazz Pharmaceuticals and Azur Pharma will become one company, the two drug makers 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 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.

January 3, 2012

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

January 3, 2012

Pharmacy technology provider PDX is partnering with Mscripts to allow existing PDX Classic and Enterprise Pharmacy System customers to add mobile to their customer-facing offerings, the companies said.

December 22, 2011

A Pfizer painkiller appears to produce a much less positive experience for recreational drug users when crushed than when administered whole, according to results of a post-marketing clinical study program.

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

Pfizer is seeking approval from the Food and Drug Administration for its investigational treatment of moderately to severely active rheumatoid arthritis.

December 19, 2011

The Food and Drug Administration has approved a drug made by Sandoz for treating yeast and other fungal infections.

December 13, 2011

Generic drug maker Amneal Pharmaceuticals has added four new executives, the company said.

December 13, 2011

The Federal Trade Commission has voted to approve Valeant's acquisitions of Dermik, a unit of French drug maker Sanofi that makes drugs for skin conditions, and Ortho Dermatologics, a division of Johnson & Johnson that also makes skin drugs.

December 12, 2011

Following months of meetings and negotiations with the drug and chemical industries, the Food and Drug Administration has released a draft of the goals of the Generic Drug User Fee Act.