Zantac Gains First OTC Approval

Glaxo's histamine H2 receptor antagonist Zantac (ranitidine) has received its first approval, in the UK, as an over-the-counter medication. The product is indicated for the symptomatic relief of heartburn, dyspepsia and hyperacidity, and will be launched to pharmacies in the first quarter of 1995.

Zantac is already available OTC in Denmark, but Glaxo has not actually launched a dedicated low-dose product there; the Danish authorities have deregulated the 150mg dose of the drug for OTC use. Regulatory submissions for OTC Zantac have been filed in all other major markets, including the USA.

The OTC version of Zantac comes in a 75mg tablet formulation, which is lower than the 150mg and 300mg tablets which remain prescription-only. It will be marketed by Warner Wellcome, the OTC link-up between Warner-Lambert and Wellcome, which was finalized in June 1994. Glaxo said it would not discuss the price of the new product until its launch.