 |
 |
 |
|
 |
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA
Consumer Update |
On this page:
Each year, the Food and Drug Administration (FDA) approves scores of generic drugs that treat a wide variety of conditions and help consumers save money.
Significant approvals for prescription products granted by FDA's Office of Generic Drugs since March 2008 include:
Used for: Treating schizophrenia, bipolar disorder, and other psychiatric conditions
Originally marketed as: Risperdal, by Ortho McNeil Janssen
Date approved: June 30, 2008
Notes: The labeling of the generic risperidone may differ from that of Risperdal because some uses of the drug are protected by patents and exclusivity.
Approval press release: www.fda.gov/bbs/topics/NEWS/2008/NEW01855.html
Used for: Treating seizures, bipolar disorder, and migraine headaches
Originally marketed as: Depakote, by Abbott Pharmaceuticals PR
Date approved: July 29, 2008
Notes: Generic divalproex sodium has the same safety warnings as Depakote, including a boxed warning that cautions about the risk of liver damage, pancreatitis, and birth defects.
Approval press release: www.fda.gov/bbs/topics/NEWS/2008/NEW01867.html
Used for: Treating moderate to severe Restless Legs Syndrome
Originally marketed as: Requip, by GlaxoSmithKline
Date approved: May 2008
Notes: Ropinirole tablets have been approved in the following dosages: 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg.
Approval press release: www.fda.gov/bbs/topics/NEWS/2008/NEW01832.html
Used for: Treating ocular hypertension (higher-than-normal pressure in the eye) and certain glaucomas
Originally marketed as: CoSopt, by Merck
Date approved: Oct. 28, 2008
Used for: Treating mild to moderate dementia of the Alzheimer's type
Originally marketed as: Razadyne (formerly Reminyl), by Ortho McNeil Janssen
Date approved: Aug. 28, 2008
Notes: In 2005, FDA and other international health authorities said they were reviewing the safety of Razadyne due to data from two clinical studies. FDA has asked the manufacturer to revise the labeling and advises patients to ask their health care professional if Razadyne is right for them.
Patient Information: Galantamine hydrobromide (marketed as Razadyne, formerly Reminyl): www.fda.gov/cder/drug/InfoSheets/patient/galantaminelPIS.pdf
Generic drugs cost about 20 percent to 70 percent 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.
Drug manufacturers develop new drugs under patents that protect their firms' investments in the products. When patents or other periods of exclusivity on the drugs expire, manufacturers can apply to FDA to sell generic versions.
FDA's Generic Initiative for Value and Efficiency (GIVE) helps increase the number of approvals of generic products. Read about it at www.fda.gov/oc/initiatives/advance/generics.html
This article appears on FDA's Consumer Health Information Web page (www.fda.gov/consumer), which features the latest updates on FDA-regulated products. Sign up for free e-mail subscriptions at www.fda.gov/consumer/consumerenews.html.
Generic Drug Roundup: March 2008
www.fda.gov/consumer/updates/genericdrugs030308.html
FDA’s GIVE Initiative
www.fda.gov/oc/initiatives/advance/generics.html
FDA’s Office of Generic Drugs
www.fda.gov/cder/ogd/
Generic Drug Approvals (by month)
www.fda.gov/cder/ogd/approvals/default.htm
Drug Information Search Tool: Drugs@FDA
www.accessdata.fda.gov/scripts/cder/drugsatfda/
Date Posted: February 2, 2009
