Development and Patents
The history of Zofran dates back to the mid-1980s when it was developed by GlaxoSmithKline in London. The drug was granted US patent protection in September 1987, followed by a use patent in June 1988. In January 1991, it received approval from the US FDA for its medical uses.
Approval and Initial Use
After obtaining US patent protection in 1987, followed by a use patent in 1988, Zofran was approved by the US FDA in January 1991 for medical use. Initially used to prevent nausea and vomiting caused by chemotherapy and radiation therapy, it later gained approval for post-surgery nausea prevention. Despite its initial approval, Zofran has not been authorized by the FDA for preventing morning sickness in pregnant women.
Generic Versions and Sales
Since its approval by the FDA in 1991, Zofran has been a prominent drug in managing nausea and vomiting. The first generic versions of Zofran were approved by the FDA in late 2006, marking a shift towards more affordable alternatives. Despite facing controversy over off-label use and safety concerns, Zofran remained a significant revenue generator, ranking as the 20th highest-selling brand name drug in the United States in 2005.
Medical Uses and FDA Approval
Zofran, also known as ondansetron, was approved by the US FDA in January 1991 to prevent nausea and vomiting caused by chemotherapy, radiation therapy, and post-surgery. It works by blocking signals in the stomach that induce these symptoms. Despite its effectiveness, Zofran is not FDA-approved for preventing morning sickness in pregnant women due to safety concerns for the fetus.
Controversies and FDA Restrictions
Zofran, known as ondansetron, faced controversies mainly regarding off-label usage and safety concerns. Despite being a top-selling drug, it has not been FDA-approved for treating morning sickness in pregnant women due to potential risks to the fetus. These controversies have led to restrictions on Zofran’s usage in certain populations, emphasizing the importance of using the drug only as prescribed by healthcare professionals.