Novartis gets FDA approval for OTC Prevacid

Novartis gains FDA approval of OTC Prevacid

Swiss drug major Novartis says that Prevacid 24HR (lansoprazole  delayed-release capsules 15mg) has been approved by the US Food and Drug  Administration as the first over-the-counter proton pump inhibitor for  the treatment of frequent heartburn since 2003. Prevacid 24HR is  expected to be available over-the-counter during this year.

Once-daily Prevacid 24HR is the first OTC PPI approved in its original  prescription formulation. It is the only PPI containing the active  ingredient lansoprazole to be approved for OTC treatment of frequent  heartburn, which is defined as that occurring two or more days per week.  In three clinical studies, Prevacid 24HR demonstrated  significantly-better efficacy in treating frequent heartburn than  placebo. Although some people experienced complete relief of symptoms  within 24 hours, it may take one to four days for full effect, the firm  noted.