/* mobile /* end mobile MEDDESKTOP: FDA's Recent Generic Drug Approvals

Tuesday, March 04, 2008

FDA's Recent Generic Drug Approvals

Each year, FDA approves scores of generic drugs that treat a variety of conditions and help consumers save money.

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.

Generic drugs are identical to their brand-name equivalents in dosage, safety, strength, quality, performance characteristics, intended use, and the way they're administered to patients.

Significant approvals granted by FDA's Office of Generic Drugs during the past year include

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

Drug manufacturers develop their new drugs under patents that protect their firms' investment in the products. When patents or other periods of exclusivity on the drugs expire, manufacturers can apply to FDA to sell generic versions.

In October 2007, FDA launched the Generic Initiative for Value and Efficiency (GIVE) to help increase the number of approvals of generic products.

GIVE will use existing resources to help FDA modernize and streamline the generic drug approval process. GIVE will also increase the variety of generic drug products available.

For More Information

FDA's GIVE Initiative
http://www.fda.gov/oc/initiatives/advance/generics.html

FDA's Office of Generic Drugs
http://www.fda.gov/cder/ogd/

Generic Drug Approvals (by month)
http://www.fda.gov/cder/ogd/approvals/default.htm

Date Posted: March 3, 2008


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