FDA Approves Generic Ambien, Fosamax, Coreg and more

Filed Under (Medicine) by User ImageCris Harshman on 04-03-2008

Tagged Under : , , , , , , ,

I was wondering why I haven’t seen any Ambien commercials lately. According to the FDA,

Generic drugs cost about 20% to 70% less than their brand name counterparts. The Congressional Budget Office has reported that generic drugs save consumers an estimated $8 billion to $10 billion a year.

Here’s a list of some of the generic drugs approved by the FDA so far this year:

  • Alendronate Sodium Tablets (Fosamax)
    Used for: Treating and preventing types of osteoporosis
    Originally marketed as: Fosamax, by Merck & Co.
    Date approved: Feb. 6, 2008
  • Carvedilol Tablets (Coreg)
    Used for: Treating hypertension and heart failure
    Originally marketed as: Coreg, by SmithKline Beecham, now GlaxoSmithKline
    Date approved: Sept. 5, 2007
  • Cetirizine HCl Tablets (Zyrtec)
    Used for: Treating symptoms of allergies
    Originally marketed as: Zyrtec, by Pfizer
    Date approved: Dec.12, 2007
  • Granisetron Tablets (Kytril)
    Used for: Preventing nausea and vomiting related to chemotherapy and radiation
    Originally marketed as: Kytril, by Roche
    Date approved: Dec. 31, 2007
  • Oxcarbazepine Tablets (Trileptal)
    Used for: Treating certain kinds of seizures and epilepsy
    Originally marketed as: Trileptal, by Novartis
    Date approved: Oct. 9, 2007
  • Pravastatin Sodium Tablets (Pravachol)
    Used for: Treating elevated cholesterol and preventing coronary events.
    Originally marketed as: Pravachol, by Bristol-Myers Squibb
    Date approved: Apr. 23, 2007
  • Zolpidem Tartrate Tablets (Ambien)
    Used for: Treating insomnia
    Originally marketed as: Ambien, by Sanofi Aventis
    Date approved: Apr. 23, 2007

For more information, the FDA’s Office of Generic Drugs maintains a frequently-updated list of generic drug approvals.

Thank you for visiting The Life Ledger. If you enjoyed this article, check out the related posts below and subscribe to our feed.

Rate this:
2.9

FDA Announces Permanent Injunction against Food Companies, Executives [Fetched Feed]

Filed Under (Feed Aggregator) by User ImageCris Harshman on 04-03-2008

Tagged Under : , , , , , ,

Fetched from Food and Drug Administration Press Releases

The U.S. Food and Drug Administration today announced that Brownwood Acres Foods Inc., Cherry Capital Services Inc. (doing business as Flavonoid Sciences) and two of their top executives have signed a consent decree that effectively prohibits the companies and their executives from manufacturing and distributing any products with claims in the label or labeling to cure, treat, mitigate or prevent diseases.

The consent decree of permanent injunction is a result of the companies and their executives making unapproved drug claims and unauthorized health claims about their products, such as “Chemicals found in Cherries may help fight diabetes.” The companies are prevented from making these claims until the products are approved by the FDA as new drugs, exempt from approval as investigational new drugs, or until the claims on the products’ label and labeling comply with the law.

Brownwood Acres Foods Inc. and Cherry Capital Services Inc. manufacture and distribute various products including juice concentrates, soft fruit gel capsules, fruit bars, dried fruits, liquid glucosamine, and salmon oil capsules.

The companies have a history of promoting unapproved claims on their product labels, brochures, and Web sites, stating that the products cure, treat, mitigate, or prevent various diseases. Most recently, the companies’ Web sites referred customers to an apparently independent Web site, which was actually controlled by Brownwood Acres’ president and contained similar unproven statements claiming benefits for their products.

The FDA can order the companies to stop manufacturing and distributing any product if they fail to comply with any provision of the consent decree, the federal Food, Drug, and Cosmetic Act or FDA regulations. The companies are also required to pay $1,000 per violation per day in the event they fail to comply with the consent decree.

Rate this:
2.9

New Era Canning Company Expands Nationwide Recall [Fetched Feed]

Filed Under (Feed Aggregator) by User ImageCris Harshman on 02-03-2008

Tagged Under : , , , , ,

Fetched from Food and Drug Administration Press Releases

The U.S. Food and Drug Administration (FDA) is alerting consumers, food service operators, and food retailers that New Era Canning Company, New Era, Mich., is broadening its nationwide recall of canned vegetable products for a third time because of the potential for its foods to be contaminated with Clostridium botulinum (C. botulinum).

Rate this:
2.9

FDA’s Strategic Plan: Charting Our Course for the Future [Fetched Feed]

Filed Under (Feed Aggregator) by User ImageCris Harshman on 02-03-2008

Tagged Under : , , , ,

Fetched from Food and Drug Administration Consumer Updates

FDA’s Strategic Action Plan sets forth the agency’s long-term strategic goals and objectives.

Rate this:
2.9

Ongoing Review of Cholesterol Drug Vytorin [Fetched Feed]

Filed Under (Feed Aggregator) by User ImageCris Harshman on 02-03-2008

Tagged Under : ,

Fetched from Food and Drug Administration Consumer Updates

FDA issued an Early Communication on January 25, 2008, announcing that it will conduct a review of Merck/Schering Plough’s recently completed study on Vytorin (ezetimibe/simvastatin) once the agency receives the final results

Rate this:
2.9

RSS