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U.S. Department of Health and Human Services

For Consumers

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Generic Drug Roundup: September 2009

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Each year, the Food and Drug Administration (FDA) approves many 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 January 2009 include:

Levetiracetam Oral Solution (100 mg/mL)

Used for: Treating certain types of seizures in people with epilepsy. It is used in combination with other medications.

Originally marketed as: Keppra Oral Solution, by UCB Pharmaceuticals Inc.

Date approved: Jan. 15, 2009

Notes: FDA requires the manufacturers of Levetiracetam (Keppra) to warn on the product’s prescribing information or labeling that use increases risk of suicidal thoughts and behaviors.

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Risperidone Oral Solution (1 mg/mL)

Used for: Treating schizophrenia, bipolar disorder, and other psychiatric disorders.

Originally marketed as: Risperdal Oral Solution by Ortho McNeil Janssen

Date approved: Jan. 30, 2009

Notes: This approval is for the oral liquid form of risperidone. Generic risperidone tablets were approved last year. This drug carries a boxed warning because it is not approved for the treatment of patients with dementia-related psychosis. Elderly patients with dementia-related psychosis treated with antipsychotic drugs may be at an increased risk of death.

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Sumatriptan Succinate Injection (6 mg [base]/0.5mL)

Used for: Treating migraine headaches once they occur.

Originally marketed as: Imitrex, by GlaxoSmithKline

Date approved: Feb. 6, 2009

Notes: This product is not effective in preventing migraines. Also, it is not to be used for other types of headaches.

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Topiramate Tablets (25, 50, 100 and 200 mg)

Used for: The generic is approved only to treat certain types of seizures in people with epilepsy. It is prescribed for use either alone or in combination with other medications.

Originally marketed as: Topamax, by Ortho-McNeil

Date approved: March 27, 2009

Notes: Prescribing information or labeling for generic topiramate will differ from Topamax because some uses of Topamax continue to be protected by patents and exclusivity. FDA requires the manufacturers of topiramate (Topamax) to warn on the products’ prescribing information or labeling that using the product increases patients' risk of suicidal thoughts and behaviors.

Physicians are advised to recommend that patients who are pregnant while using topiramate/Topamax enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this is to provide information on the effects of in utero (pre-birth) exposure to the product. For information on enrolling in NAAED, visit www.aedpregnancyregistry.org.

Read FDA's press release regarding this approval.

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Bicalutamide Tablets (50 mg)

Used for: Treating cancer that started in the prostate and has spread to other parts of the body. It's used with a luteinizing hormone-releasing hormone (LHRH) such as leuprolide or goserelin.

Originally marketed as: Casodex, by AstraZeneca

Date approved: July 6, 2009

Notes: Prescribers are instructed to use bicalutamide (Casodex) with caution in patients with liver impairment. Use in combination with a LHRH product has been shown to cause a reduction in glucose tolerance in males.

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Levonorgestrel Tablets (0.75 mg)

Used for: emergency contraception

Originally marketed as: Plan B, by Duramed Pharmaceuticals Inc.

Date approved: June 24, 2009

Notes: The generic product will be available by prescription only for women ages 17 and under. Plan B is approved for nonprescription use for women 18 years of age and older. Levonorgestrel is not effective in terminating an existing pregnancy and does not protect against sexually transmitted diseases, including HIV infection.

Read FDA's press release regarding this approval.

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Generic Drugs: Vital Facts

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 new drugs expire, manufacturers can seek approval from the FDA to sell generic versions.

FDA's Generic Initiative for Value and Efficiency (GIVE), which was launched in 2007, helps increase the number of approvals of generic products.

2009 marks the 25th anniversary of the Drug Price Competition and Patent Term Restoration Act, which is also known as the Hatch-Waxman Act. This legislation increased the availability of less costly generic drugs by allowing FDA to approve applications for generic versions of brand-name drugs without repeating the research that proved the safety and effectiveness of the brand-name drugs.

The Act also allowed brand-name companies to apply for up to five years additional patent protection for the new medicines they developed to make up for time lost while their products were going through FDA's approval process.

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

Date Posted: September 16, 2009