FDA Approves First Generic Ondansetron Tablets, Orally Disintegrating Tablets and Oral Solution

The Food and Drug Administration today approved the first generic versions of Zofran (Ondansetron) Tablets, Orally Disintegrating Tablets and Oral Solution which are indicated to prevent nausea and vomiting associated with surgery, radiotherapy and cancer chemotherapy. The approval is an important step in the agency’s effort to increase the availability of lower-cost generic medications. In 2005, Ondansetron was the 20th highest-selling brand-name drug in the United States in 2005, with sales totaling $839,256,543 as reported in the online magazine Drug Topics.

"This approval will result in significant savings for the American public," said Gary J. Buehler, director, Office of Generic Drugs. "Generic drugs are safe and effective alternatives to brand name drugs and undergo a thorough scientific and regulatory review."

The economic benefits of FDA’s generic drug approval program are significant because generic drug products, which are used to fill over 50 percent of all prescriptions, frequently cost a fraction of the price of the brand-name drugs. Such savings are likely to increase as more competitors enter the market. (See http://www.fda.gov/cder/ogd/generic_competition.htm).

The Office of Generic Drugs reviews and takes action on generic drug applications as expeditiously as possible. The same thorough and rigorously scientific review standards of safety, efficacy and quality are applied to generic drug applications as are applied to new drug applications. Consumers and health professionals can be assured that an approved generic drug is bioequivalent to a brand name drug and is its equal in dosage form, strength, route of administration, quality, performance characteristics, and intended use.

For more information on other first generic versions, please see http://www.fda.gov/cder/ogd/approvals/default.htm

Ondansetron Hydrochloride Tablets (4 mg, 8 mg, 16 mg and 24 mg) are manufactured by Dr. Reddy Laboratories, Ltd., Bridgewater, NJ 08807.

Ondansetron Orally Disintegrating Tablets (4 mg, 8 mg, 16 mg and 24 mg) are manufactured by Kali Laboratories, Inc., Somerset, NJ 08873.

Ondansetron Hydrochloride Oral Solution (4mg (base)/5 mL) is manufactured by Roxane Laboratories, Inc., Columbus, OH 43228.

For additional information related to FDA’s Office of Generic Drugs, please go to: http://www.fda.gov/cder/consumerinfo/generic_equivalence.htm.

Source: FDA Approves First Generic Ondansetron Tablets, Orally Disintegrating Tablets and Oral Solution

Posted: December 2006


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