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Consumer Update |
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
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.
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
