Taro Pharmaceutical Industries (Nasdaq: TARO) reported today that it has received tentative approval from the US 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 and for ondansetron hydrochloride tablets, equivalent to 4 mg, 8 mg and 24 mg ondansetron base respectively.
Taro’s carvedilol tablets are the generic equivalent of GlaxoSmithKline’s Coreg tablets, used in treating cardiovascular conditions, such as hypertension. According to industry sources, annual US sales of Coreg are approximately $1.1 billion. Taro expects that upon the March 2007 expiration of the patent covering the compound and its use in the treatment of hypertension, there will be other generic competition for Coreg.
Taro’s ondansetron tablets are the generic equivalent of GlaxoSmithKline's Zofran tablets. Ondansetron is a prescription pharmaceutical product used for the prevention of nausea and vomiting in patients undergoing chemotherapy and radiation therapy and in post-operative patients. According to industry sources, Zofran tablets have annual US sales of approximately $600 million. In July 2005, Taro also received tentative approval for its ANDA for ondansetron hydrochloride oral solution.
Taro also received final approval from the FDA for its ANDA for citalopram hydrobromide tablets, 10 mg, 20 mg and 40 mg. Taro’s citalopram is bioequivalent to Forest Laboratories’ Celexa tablets in the same strengths. Citalopram tablets are indicated for the treatment of depression. According to industry sources, annual US sales of citalopram tablets are approximately $176 million.
Published by Globes [online], Israel business news - www.globes.co.il - on April 24, 2006
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