US Approval For OTC Tagamet Recommended

The US Food and Drug Administration's Nonprescription Drugs Advisory Committee and Gastrointestinal Drugs Advisory Committee have recommended that SmithKline Beecham's Tagamet (cimetidine) should be approved as an over-the-counter drug for the treatment of heartburn.

Tagamet lost its patent protection in the USA last May and has seen sales of the drug fall since then. The company has had two previous attempts to gain approval for an OTC version. The last application stumbled after the advisory committee requested more evidence about possible interactions of the drug with other products after reports of drug interactions at the prescription dose level.

The OTC medication, if approved, will be known as Tagamet HB. It is intended to provide an alternative to traditional antacids which neutralize stomach acid but do not block its production, notes SB. The dose is expected to be two 100mg tablets taken up to two times a day. The prescription form will still be available in the USA, added SB.