FDA stops firm marketing unapproved cold medicines

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Posted on 10th April 2009 by Gordon Johnson in Uncategorized

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Date: 4/10/2009

WASHINGTON (AP) — Federal regulators have secured a court order barring a New Jersey pharmaceutical company from distributing more than 50 unapproved cough and cold medicines.

The Food and Drug Administration said Friday that East Windsor, N.J.-based Advent Pharmaceuticals continued to market the medications despite prior warnings from regulators. The company also failed to correct numerous manufacturing problems identified by FDA inspectors.

Drug manufacturers in the U.S. are required to submit their products to the FDA for premarket approval to guarantee they are safe and effective. The unapproved products marketed by Advent and its subsidiary Neilgen Pharmaceuticals include: BP Allergy Junior Suspension, RE All 12 Suspension and many others.

Neilgen, which also does business as Unigen Pharmaceuticals, is based in Westminster, Md.

“Consumers in possession of these products should discontinue using them and discuss FDA-approved treatments with their health care professional,” the FDA said in a statement.

Company executives Bharat Patel and Pragna Patel agreed to destroy their inventory of unapproved drugs, under a consent degree handed down in the U.S. District Court of Maryland. The agreement also bars the executives from manufacturing any new drugs without FDA approval and requires them to hire outside consultants to assess their operations before resuming production.

Company leaders did not immediately respond to calls for comment Friday afternoon.

Friday’s action comes the same week the FDA ordered a number of medical device manufacturers to submit data on products that were never approved. The devices, which range from pacemaker generators to dental implants, were released to market before the 1976 law which gave FDA authority to regulate new devices.

Copyright 2009 The Associated Press.

Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.

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Bayer sues Abbott, alleging patent infringement

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Posted on 30th December 2008 by Gordon Johnson in Uncategorized

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Date: 12/30/2008

By LINDA A. JOHNSON
AP Business Writer

TRENTON, N.J. (AP) — Pharmaceutical and chemical maker Bayer AG has filed a federal lawsuit alleging that drugmaker Abbott Laboratories’ best-selling drug, Humira, infringes on a decade-old Bayer patent.

The German company’s Bayer HealthCare LLC unit sued Abbott and two of its subsidiaries, claiming the popular biotech drug used to treat severe types of arthritis and other immune disorders infringes on the U.S. patent that Bayer was awarded in 1997.

Bayer’s lawsuit was filed six years after Humira was approved for U.S. sales — and in the plaintiff-friendly U.S. District Court for the Eastern District of Texas. The lawsuit seeks triple damages for past and future patent infringement, attorney fees and other relief, but does not seek to halt sales of Humira.

Humira, which is injected, is Abbott’s top revenue driver, with sales jumping 50 percent to $1.2 billion in the third quarter. In October, the company boosted its forecast for full-year sales to $4.4 billion.

Bayer does not have any products that compete with Humira, according to spokeswoman Marcy Funk.

North Chicago-based Abbott, which was sent a summons by the court on Tuesday, will “vigorously defend against this lawsuit,” spokesman Scott Stoffel said.

“Humira does not infringe Bayer’s patent and Abbott believes Bayer’s patent is invalid,” Stoffel said.

Humira is approved to treat several serious immune system disorders, including rheumatoid and other kinds of arthritis as well as Crohn’s disease. The drug carries the risk of serious, possibly fatal, infections, including tuberculosis.

The Bayer patent in question, No. 5,654,407, covers a genetically engineered antibody that binds to and blocks the action of a type of immune system cell called tumor necrosis factor, or TNF. TNF is one of the cytokines, the “messengers” of the immune system, and stimulates inflammation, a key problem in the conditions that Humira treats.

According to the lawsuit, filed on Dec. 24 in Tyler, Texas, Bayer chose to file in the Eastern District of Texas because Abbott and subsidiaries Abbott Bioresearch Center Inc. and Abbott Biotechnology Ltd. sell and advertise Humira there.

Bayer’s lead lawyer in the case, T. John Ward Jr., is the son of a federal judge in Marshall, Texas, who helped build the Eastern District into a patent lawsuit hotbed.

Humira competes with the drug Remicade, made by Johnson & Johnson’s Centocor unit. That company and New York University filed a patent infringement suit against Abbott in April 2007, also in the Eastern District of Texas. The case is ongoing, according to Stoffel.

Abbott has a number of patents that cover Humira, including a “composition of matter” patent that doesn’t expire until 2016, he said.

Bayer said its patent runs until August 2014.

Bayer’s top drugs include the erectile dysfunction treatment Levitra, the antibiotics Cipro and Avelox, contraceptives Mirena and Yasmin, and Glucobay for diabetes. The company also makes agricultural products, coatings and plastics.

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AP Business Writer David Koenig in Dallas contributed to this report.

Copyright 2008 The Associated Press.
Summary

Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.

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Consumer group asks government to ban Avandia

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Posted on 30th October 2008 by Gordon Johnson in Uncategorized

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Date: 10/30/2008

WASHINGTON (AP) _ The government should ban the diabetes drug Avandia because of a wide variety of life-threatening risks, including heart and liver damage, a consumer group said Thursday.

The consumer group, Public Citizen, filed a petition with the Food and Drug Administration to have Avandia taken off the market.

It was the second setback in as many weeks for the GlaxoSmithKline medication, which at one time had shown great promise in reducing the blood sugar levels of people with Type 2 diabetes. Last week, the American Diabetes Association and a European counterpart jointly released updated treatment guidelines for doctors that pointedly recommended against using Avandia.

“The FDA is in possession of clear, unequivocal evidence that (Avandia) causes a wide variety of toxicities,” Public Citizen said in its petition. “Many of these are life-threatening, such as heart attacks, heart failure (and) liver failure.”

Avandia’s heart risks were brought to light two years ago in a medical journal article that reported a 43 percent higher risk of heart attacks among Avandia patients when compared with those taking other diabetes drugs. Although scientists are still debating a link between the drug and heart attacks, concerns about the medical evidence led to stronger warnings.

As a result, Avandia use dropped sharply but about a million U.S. patients still take it.

Public Citizen said its own research found 14 cases of liver failure associated with Avandia, 12 of which led to death. The petition also said Avandia predisposes some patients to eye problems, anemia and bone fractures.

Glaxo, in a statement, said it does not believe Avandia causes liver failure. The company said its own data shows the drug has a good safety record when it comes to liver problems. The company said the data on heart attacks is inconclusive and that Avandia is safe and effective, when used according to directions.

There was no immediate response from the FDA.

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On the Net:

Public Citizen Web site: http://www.citizen.org/

Copyright 2008 The Associated Press.

Attorney Gordon Johnson
Chair Traumatic Brain Injury Litigation Group, American Association of Justice
g@gordonjohnson.com :: 800-992-9447 :: Attorney Gordon S. Johnson, Jr.

http://subtlebraininjury.com :: http://brainanatomyguide.com :: http://car-accident-rain.com :: http://tbilaw.com
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