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.
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.
