Tagged Articles

New Jersey 500 articles

FDA awaits Actavis permanent injunction

The drug company Actavis, producer of the heart drug Digitek, agreed to close several plants in New Jersey and will not resume operations at these plants until U.S. standards for testing and manufacturing have been met by the FDA. According to Pharma Tech Live, the FDA has filed a consent degree, banning Actavis from distributing drugs in Totowa and Little Falls, N.J. The agreement also gives the FDA the right to close the plants if violations persist and to fine the company $15,000 a day afterward. The FDA filed an action against Actavis Dec. 23, which was signed by Actavis on ... Read More

U.S. attorneys sue makers of Digitek, seek to close facilities

U.S. Attorneys in New Jersey are moving to close three Actavis Inc. plants, the company that manufactures Digitek, until they comply with FDA regulations. According to the Associated Press, the suit requests the court to not allow Actavis Inc. and Actavis Totowa to manufacture drugs until the company complies with FDA regulations for testing, quality control, and test response. The company must also stop selling unapproved and misbranded drugs. Filed by U.S. Attorney Christopher Cristie and the Department of Justice’s Officer of Customer Ligation, the suit states Actavis’ facilities in Totowa and Little Falls, N.J., have not only continued to ... Read More

Investigations of Vytorin marketing intensifying

Controversy surrounding the cholesterol-fighting drug Vytorin continues to escalate as federal and state prosecutors investigate Merck and Schering-Plough’s marketing of the drug. According to an article in the Wall Street Journal, many government officials suspect that the companies’ marketing of Vytorin was misleading and improper. If Vytorin ad campaigns and promotional media were based on a false or misleading premise, and the drug isn’t all its manufacturers publicized it to be (as the drug trials suggest), then government programs spent millions of dollars on reimbursement for a drug that is ineffective, possibly dangerous, and much more expensive than generic cholesterol ... Read More

FDA will not name Chinese plants that supplied tainted heparin

The U.S. Food and Drug Administration (FDA) is at odds with congressional investigators over an investigation into the federal agency’s inspection of foreign drug manufacturing facilities. The report revealed that inspecting the more than 3,000 overseas drug plants would take the FDA more than 13 years to complete The agency fired back, saying “The conclusion that FDA should endeavor to conduct foreign inspections based on the same criteria as domestic inspections is…problematic because of the differences in regulatory methodology and resources,” according to the Associated Press. The need for careful inspections of foreign drug manufacturing plants has come to the forefront ... Read More

Congress investigates FDA inspection of Actavis

On October 8, John Dingell (D-MI), chairman of the U.S. House Committee on Energy and Commerce, and Bart Stupak (D-MI), chairman of that committee’s Subcommittee on Oversight and Investigations, wrote a letter to the U.S. Food and Drug Administration Commissioner Andrew C. von Eschenbach to request more information concerning the FDA’s procedure for examining manufacturing facilities of the generic drug manufacturer Actavis after several of the company’s products were recalled. Dingell and Stupak’s letter questions not only the FDA’s inspection of the company’s facilities, but if the FDA should have allowed this company to resume its operation, even though it ... Read More

student sues for freeze-tag injuries

In West Amwell, New Jersey, an alumnus of South Hunterdon Regional High School has sued the Board of Education due to an injury the student received two years ago in a game of freeze tag. On July 10 of this year, Alexandria Nalborne filed a personal injury lawsuit at the Hunterdon County State Superior Court in Flemington according to The Packett. The suit states that Nalborne received “severe bodily injuries” as a game of freeze tag resulted in another student shoving Nalborne into a lawn mower. The Packett reports Board of Education President, Bob Campell, was aware a student was harmed, but ... Read More

Actavis recalls more than 65 drugs

Actavis Totowa, the drug manufacturer of Digitek, just announced a voluntary recall, to the retail level, of more than 65 generic drug products manufactured at its Little Falls, New Jersey, facility, according to a release on the company web site. This recall follows an inspection conducted by the Food & Drug Administration, earlier this year, which revealed that operations at the New Jersey facility did not meet FDA standards. Digitek was recalled in April 2008 after it was discovered that tablets may have been manufactured at twice their intended thickness, doubling the amount of medication in the pills and putting ... Read More

Dark side of Chantix comes to light

Once hailed as a miracle drug for helping people to stop smoking, Pfizer’s Chantix has recently raised concerns as reports surface that it may have a disturbing side effect – suicidal thoughts and actions. A report in the New Jersey Star-Ledger notes that the FDA is investigating reports of a number of serious psychological side effects. In additon to suicidal actions, reports include agitation and depression. As a result of these reports, the FDA issued a public advisory, and required new safety warnings on the label. However, the FDA said it is still not sure if the side effects are ... Read More

J&J pays $1.25m to settle lawuit over death of 14-year-old

Johnson & Johnson agreed to pay $1.25 million to settle a lawsuit over the death of a 14-year-old girl who used the company’s Ortho Evra birth-control patch, according to court records. The confidential agreement involved Alycia Brown, a resident of LaCrosse, Wisconsin, who suffered two blood clots in her lungs on May 7, 2004, after using the patch for several weeks. J&J, the world’s largest maker of health-care products, faces lawsuits by 2,400 of the 5 million women who used the patch. Most claim they suffered strokes or clots in their legs or lungs. The company settled dozens of cases ... Read More

Wyeth must pay $134.1 million in menopause drug lawsuit

Wyeth must pay $134.1 million, including $99 million in punitive damages, over its mishandling of menopause drugs that helped cause three Nevada women’s cancers, a jury ruled. The panel ruled Oct. 12 that the company owed the women $35.1 million in compensatory damages. Jurors in state court in Reno concluded today that Wyeth, the largest maker of hormone- replacement medicines, should also pay Arlene Rowatt, Jeraldine Scofield and Pamela Forrester punitive damages for concealing the breast-cancer risks of its Prempro and Premarin drugs. “We got the word out that a lot of women have been injured by this type of ... Read More