FDA tentatively approves Taro's Carvedilol Tablets, Ondansetron HCL Tablets

By Lisa Kerner

Erie, Pa., April 24 - Taro Pharmaceutical Industries Ltd. said it received tentative approval from the Food and Drug Administration for its abbreviated New Drug Applications for Carvedilol Tablets (3.125 mg, 6.25 mg, 12.5 mg and 25 mg) and for Ondansetron Hydrochloride Tablets (equivalent to 4 mg, 8 mg and 24 mg Ondansetron base).

The FDA determined that Taro's Carvedilol Tablets are safe and effective for use when compared with GlaxoSmithKline's Coreg Tablets for the treatment of cardiovascular conditions, including hypertension. With annual U.S. sales of about $1.1 billion, Coreg will have generic competition when its patent expires in March 2007, according to a company news release.

Taro's Ondansetron, for the prevention of nausea and vomiting in patients post-surgery or undergoing chemotherapy or radiation therapies, was determined by the FDA to safe and effective for use when compared with GlaxoSmithKline's Zofran Tablets in the same strengths. According to industry sources, Zofran Tablets have annual U.S. sales of about $600 million.

In July 2005, Taros said it received tentative approval for its aNDA for Ondansetron Hydrochloride Oral Solution.

Taro received final aNDA approval from the FDA in March for Citalopram Hydrobromide Tablets, 10 mg, 20 mg and 40 mg, the company's bioequivalent to Forest Laboratories' Celexa Tablets in the same strengths, for the treatment of depression. Annual U.S. sales of citalopram tablets are about $176 million.

Taro is a multinational, science-based pharmaceutical company located in Hawthorne, N.Y.

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