News
Taro Receives Tentative ANDA Approvals For Carvedilol Tablets
Hawthorne, N.Y.(PRIMEZONE) -- Taro Pharmaceutical Industries Ltd. and its affiliates and subsidiaries (Nasdaq: TARO) reported today that it has received tentative approval from the U.S. Food and Drug Administration ("FDA") for its Abbreviated New Drug Applications ("ANDA") for Carvedilol Tablets, 3.125 mg, 6.25 mg, 12.5 mg and 25 mg ("carvedilol tablets") and for Ondansetron Hydrochloride Tablets, equivalent to 4 mg, 8 mg and 24 mg ondansetron base respectively ("ondansetron tablets").
The tentative ANDA approvals for Taro's carvedilol tablets, received April 21, 2006, and ondansetron tablets, received earlier this month, are FDA determinations that Taro's ANDA submissions for these products currently satisfy the substantive requirements for approval, subject to the expiration of all relevant patents or statutorily imposed exclusivities, restrictions and 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.
Carvedilol Tablets
The FDA has determined that Taro's carvedilol tablets are safe and effective for use when compared with the reference listed drug product, GlaxoSmithKline's Coreg(R) Tablets. Coreg(R) is a prescription product used in treating cardiovascular conditions, such as hypertension. According to industry sources, annual U.S. sales of Coreg(R) are approximately $1.1 billion. It is expected, as allowed under applicable law, that upon the March 2007 expiration of the patent covering the compound and its use in the treatment of hypertension, there will be generic competition for Coreg(R).