The Food and Drug Administration on Tuesday unveiled new restrictions for Accutane, a drug indicated for the treatment of a specific type of severe acne that is not responsive to other therapies.
The goal of the strengthened risk minimization action plan (RiskMAP) for Accutane and its generic equivalents is to reduce the risk of birth defects [...]

The Food and Drug Administration last week pulled from the market VITERA-XT, an ephedra-containing dietary supplement, which was was marketed as a treatment for serious diseases and conditions.
The complaint, filed by the United States Attorney for the Southern District of Texas in U.S. District Court in Houston, charges that VITERA-XT, marketed by Houston-based Asia MedLabs, [...]

Dr. David Graham, a Food and Drug Administration official, told the Senate Finance Committee last Friday that the FDA would be unable to protect the country from another Vioxx case.
Vioxx was pulled from all worldwide markets by Merck & Company, after a study confirmed that the popular arthritis drug increases a patients’ risk of heart [...]

A California regulator filed a lawsuit against Universal Life Resources of San Diego and four major insurance companies, accusing them of hiding millions of dollars in secret commissions. During a press conference, Commissioner Garamendi announced that a settlement had been reached with Universal Life requiring the broker to end these practices immediately.
“These brokers and insurers [...]

A national Vioxx class action lawsuit was filed against Merck & Company on behalf of people who were injured by the arthritis drug, Attorney J. Douglas Peters, a senior shareholder with Charfoos & Christensen, P.C. in Detroit, Michigan, said on Thursday in a press release.
“The Vioxx cases and the negligence surrounding Merck’s development, marketing and [...]

U.S District Court Judge Susan Illston approved on Tuesday the settlement of a class action lawsuit, Gonzalez v. Abercrombie & Fitch, requires the retail clothing giant to pay $40 million dollars to Latino, African American, Asian American and women applicants and employees who charged the company with discrimination.
The settlement also requires the company to institute [...]

A class action lawsuit filed against Bayer AG on behalf of consumers and third party payors regarding the antibiotic drug Cipro has been certified, plaintiffs’ attorneys said on Monday in a press release.
The lawsuit, filed in San Diego Superior Court, alleges that the defendants agreed not to compete with each other, and thereby prevented a [...]

A United States law firm has been hired to investigate if a link exists between the controversial anti-malaria drug Lariam made by Hoffmann-La Roche and the severe psychiatric problems suffered by hundreds of elite Australian soldiers.
Lariam is a popular malaria prevention drug prescribed to thousands of U.S. travelers and military personnel as well as soldiers [...]

The Food and Drug Administration and three pharmaceutical companies today announced an initiative to combat drug counterfeiting and fraud by putting radio frequency identification technology on the labels of drug bottles.
This action continues the FDA’s commitment to promote the use of RFID technology by the U.S. drug supply chain by 2007.
The first drugs to get [...]

U.S. Food and Drug Administration announced today important safety changes to the labeling of the abortion pill Mifeprex, also known as RU-486, after receiving reports linking the drug to serious bacterial infection.
Mifeprex, made by Danco Laboratories, was approved in 2000 for the termination of early pregnancy, defined as 49 days or less.
Both the F.D.A. and [...]