The FDA has approved a generic DuoNeb medication that will be manufactured by Sandoz Pharmaceuticals. However, this generic version is not yet available. It is unknown exactly why generic DuoNeb is not yet available, but it could be because of lawsuits or settlements between the manufacturer of DuoNeb and Sandoz Pharmaceuticals.
DuoNeb is made by Dey, L.P. The U.S. Food and Drug Administration (FDA) has approved a generic version of DuoNeb that will be manufactured by Sandoz Pharmaceuticals. However, this product is not yet available.
When Will Generic DuoNeb Be Available?
This is a difficult question to answer. Even though generic DuoNeb has been approved by the FDA, Sandoz Pharmaceuticals has not yet "launched" the product. This may be the result of ongoing lawsuits or settlements between Sandoz and the manufacturer of DuoNeb. Because these settlements are usually kept confidential, it is difficult to know exactly why Sandoz has not launched their generic DuoNeb product yet. Once Sandoz begins selling it, no other company can sell a similar product for 180 days.
What About Compounded Generic DuoNeb?
Sometimes, pharmacies make their own medications. Typically, this is done to meet the needs of a specific patient who needs a medication in a different strength or form than what is commercially available. This is known as compounding. Compounding should not be performed in order to provide a "generic" or less expensive version of a commercially available medication. Compounded ipratropium and albuterol nebulizer solutions are not equivalent to DuoNeb and should not be considered generic versions of it.
Written by/reviewed by: Kristi Monson, PharmD;Arthur Schoenstadt, MD
Food and Drug Administration, Center for Drug Evaluation and Research. Electronic orange book: Approved drug products with therapeutic equivalence evaluations. FDA Web site. Available at: http://www.fda.gov/cder/ob/. Accessed September 7, 2007.
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