FDA approves morning sickness therapy.

The AP (4/9) reports that a Food and Drug Administration announcement Monday, "means a new version" of Bendectin (doxylamine, dicyclomine and pyridoxine), is "set to return to US pharmacies" under the brand name Diclegis (doxylamine succinate and pyridoxine hydrochloride), as a "safe and effective treatment" for morning sickness, or pregnancy-related nausea. At the time when lawsuits involving Bendectin began, the FDA "continued to call the drug safe; appeals courts ruled in favor of Bendectin maker Merrell Dow Pharmaceuticals; and eventually a US Supreme Court decision would render continuing suits unlikely." But in 1983, Merrell Dow stopped producing Bendectin, citing the high litigation costs as the reason. Diclegis, which is manufactured by the privately held Canadian company Duchesnay Inc., is expected to be available on the US market in the beginning of June.

        Reuters (4/9, Clarke, Berkrot) adds that in a statement announcing the FDA approval, the Blainville, Quebec-based drug maker noted that doxylamine is a common ingredient in many antihistamines that are available over-the-counter and pyroxidine is vitamin B6. A generic version of Diclegis - Diclectin (doxylamine 10 mg/pyridoxine 10 mg delayed-release) - has been available in Canada for the past 30 years.