Friday 18 April, 2008

Teva got tentative approval from USFDA for Rizatriptan Benzoate

Teva announced that the USFDA has granted tentative approval for the Company's ANDA to market its generic version of Merck's migraine pain treatment Maxalt(R) (Rizatriptan Benzoate) Tablets, equivalent to 5 mg and 10 mg base. Final approval of this product is anticipated upon expiration of patent protection for the brand product in June 2012.
Rizatriptan (N,N-dimethyl-2-[5-(1,2,4-triazol-1-ylmethyl)-1H-indol-3-yl]ethanamine, Maxalt®) is a triptan was developed by Merck & Co. for the treatment of migraine headaches. It is available in strengths of 5 and 10 mg as tablets and orally disintegrating tablets (Maxalt-MLT).
Maxalt obtained approval by the USFDA on June 29, 1998. It is a second-generation triptan.
The brand product had annual sales of approximately $193 million in the United States for the twelve months that ended December 30, 2007, based on IMS sales data.

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