FDA APPROVES ACTAVIS' GENERIC ZANTAC SYRUP

Actavis has received FDA approval to market generic ranitidine oral solution. Due to Actavis's first-to-file status, the FDA has granted the company a 180-day period of marketing exclusivity.

The product, which is the generic equivalent of GlaxoSmithKline's Zantac Syrup, will be available in the 15-mg/mL size. Zantac is indicated for the treatment and prevention of ulcers and gastroesophageal reflux disorder and to treat conditions caused by high acid secretion.

"The FDA approval for ranitidine represents one of the most significant product launches in the U.S. market," Robert Wessman, president and CEO of Actavis, said.

Sales of ranitidine syrup in the U.S. were approximately $121 million in 2006, according to IMS Health data.