Taro Pharmaceutical Industries Ltd. has received tentative approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application for ranitidine syrup (Ranitidine Oral Solution USP), 15 mg/mL (ranitidine syrup).
Ranitidine syrup is a prescription product used for the treatment of ulcers, gastroesophageal reflux disease, or GERD, and other gastro-intestinal disorders. The FDA has determined that Taro's ranitidine syrup is safe and effective for use when compared with the reference listed drug product, GlaxoSmithKline's Zantac syrup, 15 mg/mL.
The tentative ANDA approval for Taro's ranitidine syrup is an FDA determination that Taro's ANDA submission for this product currently satisfies the substantive requirements for approval, subject to the expiration of all relevant patents or statutorily imposed exclusivities and restrictions (currently expected to occur during May 2009), or any new information that may come to the FDA's attention. Tentative approvals do not grant marketing rights; a company may only market a product upon receiving final approval for an ANDA submission.
According to industry sources, Zantac Syrup has annual US sales of approximately $125 million. It is expected that when Taro receives final FDA approval of its ANDA, there will be additional generic competition for Zantac syrup.