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www.fdanews.com/articles/90783-taro-receives-tentative-approval-for-generic-zantac-syrup

TARO RECEIVES TENTATIVE APPROVAL FOR GENERIC ZANTAC SYRUP

February 27, 2007

Taro Pharmaceutical Industries announced it has received tentative approval from the FDA for its abbreviated new drug application (ANDA) for ranitidine syrup, 15 mg/mL.

Tentative approvals do not grant marketing rights; a company may only market a product upon receiving final approval for an ANDA submission, according to the company.

The product is the generic version of GlaxoSmithKline's Zantac Syrup, which is indicated for the treatment of ulcers, gastroesophageal reflux disease and other gastrointestinal disorders.

Zantac Syrup has annual U.S. sales of approximately $125 million, according to Taro. The company expects that when it receives final FDA approval for the product there will be additional generic competition for ranitidine syrup.