After being withdrawn due to litigation, the drug has been approved by the FDA
The US Food and Drug Administration (FDA) has approved a drug for morning sickness, 30 years after it was originally removed from the market.
Diclegis (doxylamine succinate and pyridoxine hydrochloride), contains the same active ingredients as Benedictin, which was produced by Merrel Dow and withdrawn from the market in 1983 after a string of lawsuits claiming it caused birth defects.
Rather than fight the litigations, Merrel Dow voluntarily withdrew the product. However, Canadian company Duchesnay continued to market the drug in Canada, under the name Diclectin. Large scale studies have shown the drug to be safe for both mothers and foetuses, so Duchesnay has now decided to expand into the US by applying for approval of its long-release version.
The drug has been approved for use by pregnant women whose morning sickness cannot be controlled through dietary means, such as by eating smaller meals of bland food throughout the day.
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