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

tag: FDA Approval, Drug Approvals, Alendronate Sodium Tablets, osteoporosis, Fosamax, Carvedilol Tablets, hypertension, Cetirizine HCl Tablets, Zyrtec, Granisetron Tablets, Kytril, Oxcarbazepine Tablets, Trileptal, Pravastatin Sodium Tablets, Pravachol, Zolpidem Tartrate Tablets, Ambien,